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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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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.
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)
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
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
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
Automated Blood Collection System
TERUMO BCT, INC.
81000
In Commercial Distribution

  • 05020583810006 ()


  • Apheresis system
Terumo Sterile Tubing Welder
TERUMO BCT, INC.
62000
In Commercial Distribution

  • 05020583620001 ()


  • Package sealing unit
Vista® Information System Version 4 Vista Standard Interface and SafeTrace® BBSI Installation Guide
TERUMO BCT, INC.
25203
In Commercial Distribution

  • 05020583252035 ()


  • Blood bank information system
Information System Version 4, Vista Standard Interface and SafeTrace® BBSI Installation Guide
TERUMO BCT, INC.
25202
In Commercial Distribution

  • 05020583252028 ()


  • Blood bank information system
Vista Information System, Version 4.2
TERUMO BCT, INC.
25201
In Commercial Distribution

  • 05020583252011 ()


  • Blood bank information system
Single-Needle Extended Life Platelet Set With LRS® Chamber
TERUMO BCT, INC.
70400
Not in Commercial Distribution

  • 05020583704008 ()
  • 35020583704009 ()


  • Blood transfer set
Sterile Tubing Welder
TERUMO BCT, INC.
62001
In Commercial Distribution

  • 05020583620018 ()


  • Package sealing unit
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
NexLynk DMS version 4.x.x
HAEMONETICS CORPORATION
4.x.x
In Commercial Distribution

  • 00812747010187 ()


  • Blood bank information system application software
SafeTrace Tx version 3.x.x
HAEMONETICS CORPORATION
3.x.x
In Commercial Distribution

  • 00812747010101 ()


  • Blood bank information system application software
BloodTrack version 4.x.x
HAEMONETICS CORPORATION
4.x.x
In Commercial Distribution

  • 00812747010002 ()


  • Clinical laboratory information system application software
Modified LISS-Enhancement media for TANGO instruments and tube test; 50 ml
Bio-Rad Medical Diagnostics GmbH
805200100
In Commercial Distribution

  • 07611969965731 ()
805200100

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
Modified LISS-Enhancement media for TANGO instruments and tube test; 50 ml
Bio-Rad Medical Diagnostics GmbH
805200100
In Commercial Distribution

  • 07611969950898 ()
805200100

  • Low ionic-strength salt solution (LISS) immunohaematology reagent IVD
PCS2, LIST NO,06002-110-EXP-EW
HAEMONETICS CORPORATION
06002-110-EXP-EW
In Commercial Distribution

  • 30812747011970 ()


  • Autotransfusion system blood component processing set
For Collection of Two Leukoreduced Red Blood Cell Products by Centrifugation. For Use With the ALYX™ System. Sterile Fluid Path.
FENWAL, INC.
4R5720
In Commercial Distribution

  • 10811137010124 ()
  • 00811137010127 ()
4R5720

  • Apheresis system tubing set
Xenoscope, 0°, 10mm x 36 cm
XENOCOR, INC.
XS-0-1036
In Commercial Distribution

  • 00854490007007 ()
XS-0-1036

  • Rigid video laparoscope
  • Rigid-tip video laparoscope/thoracoscope, reusable
No Description
Dental Savings Club Inc
Mister-X-#0
In Commercial Distribution

  • D9021002003 ()


  • Dental digital imaging sensor, intraoral
No Description
OVERFIBERS SRL
Hi-Rem+ # 0
In Commercial Distribution

  • 08059388443260 ()
  • 08059388441655 ()
RHP600

  • Root canal post, preformed
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

  • 04047844018439 ()

  • 14x11x20mm
TK141120

  • Polymeric 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

  • 04047844018422 ()

  • 13x11x20mm
TK131120

  • Polymeric spinal interbody fusion cage
The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Titanium TETRIS™. The basic shape of these implants is a hollow structural frame. The superior and inferior surfaces are open with spikes that assist with anchoring and seating the implant between the vertebral bodies. The devices are available in a variety of dimensional sizes with or without angulation thereby 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

  • 04047844009376 ()

  • 18x15x48mm
NV001848

  • Polymeric spinal interbody fusion cage
The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Titanium TETRIS™. The basic shape of these implants is a hollow structural frame. The superior and inferior surfaces are open with spikes that assist with anchoring and seating the implant between the vertebral bodies. The devices are available in a variety of dimensional sizes with or without angulation thereby 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

  • 04047844009369 ()

  • 16x15x48mm
NV001648

  • Polymeric spinal interbody fusion cage
The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Titanium TETRIS™. The basic shape of these implants is a hollow structural frame. The superior and inferior surfaces are open with spikes that assist with anchoring and seating the implant between the vertebral bodies. The devices are available in a variety of dimensional sizes with or without angulation thereby 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

  • 04047844009352 ()

  • 14x15x48mm
NV001448

  • Polymeric spinal interbody fusion cage
The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Titanium TETRIS™. The basic shape of these implants is a hollow structural frame. The superior and inferior surfaces are open with spikes that assist with anchoring and seating the implant between the vertebral bodies. The devices are available in a variety of dimensional sizes with or without angulation thereby 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

  • 04047844009345 ()

  • 12x15x48mm
NV001248

  • Polymeric spinal interbody fusion cage
The SIGNUS group of cages includes the KIMBA®, KIMBA® mini, MOBIS®, NOVAL™, SEMIAL®, PEEK TETRIS™ and Titanium TETRIS™. The basic shape of these implants is a hollow structural frame. The superior and inferior surfaces are open with spikes that assist with anchoring and seating the implant between the vertebral bodies. The devices are available in a variety of dimensional sizes with or without angulation thereby 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

  • 04047844009338 ()

  • 10x15x48mm
NV001048

  • Polymeric spinal interbody fusion cage
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