Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Titanium TETRIS™devices is a hollow structural frame. The upper and lower aspects of the implant are open. Surface spikes assist in the positive anchorage and seating of the implant between the vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.
SIGNUS Medizintechnik GmbH
Lumbar cage, straight
In Commercial Distribution

  • 04047844000953 ()

  • 9x11x24mm
T0911

  • Metallic spinal interbody fusion cage
The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Titanium TETRIS™devices is a hollow structural frame. The upper and lower aspects of the implant are open. Surface spikes assist in the positive anchorage and seating of the implant between the vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.
SIGNUS Medizintechnik GmbH
Lumbar cage, straight
In Commercial Distribution

  • 04047844000946 ()

  • 8x11x24mm
T0811

  • Metallic spinal interbody fusion cage
The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Titanium TETRIS™devices is a hollow structural frame. The upper and lower aspects of the implant are open. Surface spikes assist in the positive anchorage and seating of the implant between the vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.
SIGNUS Medizintechnik GmbH
Lumbar cage, straight
In Commercial Distribution

  • 04047844000939 ()

  • 7x11x24mm
T0711

  • Metallic spinal interbody fusion cage
The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, straight
In Commercial Distribution

  • 04047844000335 ()

  • 10x12x14mm
P101214

  • Metallic spinal interbody fusion cage
The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, straight
In Commercial Distribution

  • 04047844000328 ()

  • 9x12x14mm
P091214

  • Metallic spinal interbody fusion cage
The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, straight
In Commercial Distribution

  • 04047844000311 ()

  • 8x12x16mm
P081216

  • Metallic spinal interbody fusion cage
The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, straight
In Commercial Distribution

  • 04047844000304 ()

  • 8x12x14mm
P081214

  • Metallic spinal interbody fusion cage
The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, straight
In Commercial Distribution

  • 04047844000298 ()

  • 8x12x12mm
P081212

  • Metallic spinal interbody fusion cage
The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, straight
In Commercial Distribution

  • 04047844000281 ()

  • 7x12x16mm
P071216

  • Metallic spinal interbody fusion cage
The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, straight
In Commercial Distribution

  • 04047844000274 ()

  • 7x12x12mm
P071212

  • Metallic spinal interbody fusion cage
The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, straight
In Commercial Distribution

  • 04047844000267 ()

  • 6x12x16mm
P061216

  • Metallic spinal interbody fusion cage
The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, straight
In Commercial Distribution

  • 04047844000250 ()

  • 6x12x12mm
P061212

  • Metallic spinal interbody fusion cage
The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, straight
In Commercial Distribution

  • 04047844000243 ()

  • 5x12x16mm
P051216

  • Metallic spinal interbody fusion cage
The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, straight
In Commercial Distribution

  • 04047844000236 ()

  • 5x12x12mm
P051212

  • Metallic spinal interbody fusion cage
The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, straight
In Commercial Distribution

  • 04047844000229 ()

  • 4x12x16mm
P041216

  • Metallic spinal interbody fusion cage
The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, straight
In Commercial Distribution

  • 04047844000212 ()

  • 4x12x12mm
P041212

  • Metallic spinal interbody fusion cage
The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, straight
In Commercial Distribution

  • 04047844000205 ()

  • 3x12x12mm
P031212

  • Metallic spinal interbody fusion cage
The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, straight
In Commercial Distribution

  • 04047844000052 ()

  • 7x12x14mm
P071214

  • Metallic spinal interbody fusion cage
The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, straight
In Commercial Distribution

  • 04047844000045 ()

  • 6x12x14mm
P061214

  • Metallic spinal interbody fusion cage
The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, straight
In Commercial Distribution

  • 04047844000038 ()

  • 5x12x14mm
P051214

  • Metallic spinal interbody fusion cage
The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, straight
In Commercial Distribution

  • 04047844000021 ()

  • 4x12x14mm
P041214

  • Metallic spinal interbody fusion cage
The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage, straight
In Commercial Distribution

  • 04047844000014 ()

  • 3x12x14mm
P031214

  • Metallic spinal interbody fusion cage
ART PRP 2-Step Processing Kit - Mini - w/o blood draw
Celling Biosciences
1651-0002
In Commercial Distribution

  • 00817771028870 ()
1651-0002

  • Haematological concentrate system preparation kit, platelet concentration
ART PRP 2-Step Processing Kit - 120
Celling Biosciences
1651-0005
In Commercial Distribution

  • 00817771028856 ()
1651-0005

  • Haematological concentrate system preparation kit, platelet concentration
ART PRP 2-Step Processing Kit - 60
Celling Biosciences
1651-0004
In Commercial Distribution

  • 00817771028825 ()
1651-0004

  • Haematological concentrate system preparation kit, platelet concentration
RBC DE-GLYCEROL./CELL WASH SET
HAEMONETICS CORPORATION
00235-00
In Commercial Distribution

  • 30812747015015 ()
  • 10812747015011 ()

  • Total Volume: 225 Milliliter
  • Total Volume: 5 Liter
  • Total Volume: 600 Milliliter


  • Blood cell freeze/thaw system set
RBC GLYCEROLIZATION SET
HAEMONETICS CORPORATION
00225-00
In Commercial Distribution

  • 30812747015008 ()
  • 10812747015004 ()


  • Blood cell freeze/thaw system set
The FIBRINET® Accessory Kit contains accessories to the FIBRINET® System. The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. The FIBRINET® Accessory Kit is available as a single pack (item number 510357) or as a multipack of 5 individually packaged kits (item number 510357-5). The FIBRINET® Accessory Kit contains 1 disposable centrifuge carrier with insert and cap and 1 - 50 mL Falcon® tube.
VERTICAL SPINE, LLC
510357
In Commercial Distribution

  • 30851802007084 ()
  • 10851802007080 ()

  • Total Volume: 50 Milliliter
510357

  • Haematological concentrate system preparation kit, platelet concentration
The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. The 27 mL FIBRINET® System is available as a single pack (item number 510358) or as a multipack of 5 individually packaged kits (item number 510358-5). The 27 mL FIBRINET® System contains 3 blood collection tubes with yellow stoppers containing buffered sodium citrate solution anticoagulant and plasma separator gel for preparing PRP, 1 PRFM tube containing calcium chloride solution with red stopper, one 30 mL membrane vial with closure containing calcium chloride solution, 1 latex free disposable tourniquet, 2 BD Vacutainer® Luer-Lok™ access devices, 1 BD Vacutainer® blood collection set with Safety-Lok® needle and 12" tubing preassembled, 2 BD Vacutainer® Blood transfer devices, and 1 vial adapter.
VERTICAL SPINE, LLC
510358
In Commercial Distribution

  • 30851802007077 ()
  • 10851802007073 ()

  • Total Volume: 27 Milliliter
510358

  • Haematological concentrate system preparation kit, platelet concentration
The FIBRINET® System is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient point of care. The PRP is mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics. The 45 mL FIBRINET® System is available as a single pack (item number 510359) or as a multipack of 5 individually packaged kits (item number 510359-5). The 45 mL FIBRINET® System contains 5 blood collection tubes with yellow stoppers containing buffered sodium citrate solution anticoagulant and plasma separator gel for preparing PRP, 1 PRFM tube containing calcium chloride solution with red stopper, two 30 mL membrane vials with closure containing calcium chloride solution, 1 latex free disposable tourniquet, 2 BD Vacutainer® Luer-Lok™ access devices, 1 BD Vacutainer® blood collection set with Safety-Lok® needle and 12" tubing preassembled, 2 BD Vacutainer® Blood transfer devices, and 1 vial adapter.
VERTICAL SPINE, LLC
510359
In Commercial Distribution

  • 30851802007060 ()
  • 10851802007066 ()

  • Total Volume: 45 Milliliter
510359

  • Haematological concentrate system preparation kit, platelet concentration
ADAM-rWBC System is composted ADAM-rWBC(equipment) and ADAM-rWBC kit (reagent). This system is intended to be used for the qualitative determination of the residual white blood cell (leukocyte) count in human specimen.
NanoEnTek, Inc.
ADAM-rWBC System
In Commercial Distribution

  • 08809317540276 ()
ADAM-rWBC System

  • White blood cell count IVD, kit, cell count
It is used for the quantitative determination of the residual white blood cell (leukocyte) count in a human specimen using ADAM-rWBC.
NanoEnTek, Inc.
AD1K-050
In Commercial Distribution

  • 08809317540269 ()
AD1K-050

  • White blood cell count IVD, reagent
For Use with Pak12G
IMMUCOR GTI DIAGNOSTICS, INC.
404597
Not in Commercial Distribution

  • 10888234500612 ()
404597

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with Pak12
IMMUCOR GTI DIAGNOSTICS, INC.
404596
Not in Commercial Distribution

  • 10888234500605 ()
404596

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with Pak12G
IMMUCOR GTI DIAGNOSTICS, INC.
404573
Not in Commercial Distribution

  • 10888234500513 ()
404573

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with Pak12
IMMUCOR GTI DIAGNOSTICS, INC.
404572
Not in Commercial Distribution

  • 10888234500506 ()
404572

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with Pak2-LE
IMMUCOR GTI DIAGNOSTICS, INC.
404558
Not in Commercial Distribution

  • 10888234500469 ()
404558

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
For Use with Pak12G
IMMUCOR GTI DIAGNOSTICS, INC.
404557
Not in Commercial Distribution

  • 10888234500452 ()
404557

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent
Pak12G assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect IgG antibodies to HLA class I antigens and to epitopes on the platelet glycoproteins IIb/IIIa, Ia/IIa, and Ib/IX.
IMMUCOR GTI DIAGNOSTICS, INC.
PAK12G
Not in Commercial Distribution

  • 10888234500223 ()
PAK12G

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, enzyme immunoassay (EIA)
Pak12 assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect antibodies to HLA class I antigens and to epitopes on the platelet glycoproteins IIb/IIIa, Ia/IIa, and Ib/IX.
IMMUCOR GTI DIAGNOSTICS, INC.
PAK12
Not in Commercial Distribution

  • 10888234500216 ()
PAK12

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, enzyme immunoassay (EIA)
ImmuLINK is middleware software that allows the user to link the application software database on automated (and/or semi-automated) blood bank instruments; the user may also link the instrument database(s) with the user’s Laboratory Information System (LIS). ImmuLINK is software designed to provide an interface between the user, blood bank instruments, and Blood Establishment Computer. ImmuLINK allows integration of sample, donor, or patient data that has been collected from multiple sources and provides data management tools to create customizable reports from the diverse data.
IMMUCOR, INC.
0030311
In Commercial Distribution

  • 10888234002475 ()


  • Laboratory instrument/analyser application software IVD
Automated plasmapheresis system designed to collect virtually cell-free plasma by membrane filtration using single-use disposable sets. Collected plasma is to be processed as Source Plasma.
Fresenius Kabi AG
6R4601
In Commercial Distribution

  • 04086000100236 ()
6R4601

  • Apheresis system
For Collection of Two Leukoreduced Red Blood Cell Products by Centrifugation. For Use With the ALYX System. Sterile Fluid Path.
Fresenius Kabi AG
X4R5720
In Commercial Distribution

  • 04086000100199 ()
  • 14086000100196 ()
X4R5720

  • Apheresis system tubing set
Software version for Aurora Xi.
Fresenius Kabi AG
1.1
In Commercial Distribution

  • 04086000101516 ()


  • Apheresis system
For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
4R2367
In Commercial Distribution

  • 14086000100998 ()
  • 04086000100991 ()
4R2367

  • Apheresis system tubing set
For Extended Platelet Storage and Plasma Collection. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
4R2365
In Commercial Distribution

  • 04086000100984 ()
  • 14086000100981 ()
4R2365

  • Apheresis system tubing set
Platelet Pool and Store Set with In-line Leukocyte Redcution Filter
HAEMONETICS CORPORATION
732-83
In Commercial Distribution

  • 30887691310691 ()
  • 10887691310697 ()


  • Blood/tissue storage/culture container
Automated Blood Collection System
TERUMO BCT, INC.
81002
In Commercial Distribution

  • 05020583810020 ()


  • Apheresis system
Sterile Tubing Welder
TERUMO BCT, INC.
62001
In Commercial Distribution

  • 05020583620018 ()


  • Package sealing unit
Automated Blood Collection System
TERUMO BCT, INC.
81000
In Commercial Distribution

  • 05020583810006 ()


  • Apheresis system
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