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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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ARGENCO 5 - D818109495

Gold based noble metal
ARGEN CORPORATION, THE
109495
In Commercial Distribution

  • D818109495 ()
109495

  • Dental casting noble alloy

sentida 5 - 04050621100449

Basic electric home bed
WISSNER-BOSSERHOFF GmbH
19-1119
In Commercial Distribution

  • 04050621100449 ()


  • Basic electric home bed

HEALON 5 - 00385445083215

HEALON 5 23 MG/ML 0.60 ML US
JOHNSON & JOHNSON SURGICAL VISION, INC.
10290051
In Commercial Distribution

  • 00385445083215 ()
10290051

  • Vitreous/aqueous humour replacement medium, intraoperative

ergoselect 5 - 04059358003740

No Description
ergoline GmbH
191004
In Commercial Distribution

  • 04059358003740 ()


  • Bicycle ergometer

RABEA 5° - 04047844014059

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, angled
In Commercial Distribution

  • 04047844014059 ()

  • 10x12x12mm
WK101212

  • Polymeric spinal interbody fusion cage

RABEA 5° - 04047844014042

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, angled
In Commercial Distribution

  • 04047844014042 ()

  • 9x12x12mm
WK091212

  • Polymeric spinal interbody fusion cage

NOVAL 5° - 04047844009987

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, angled
In Commercial Distribution

  • 04047844009987 ()

  • 18x15x48mm
NV051848

  • Polymeric spinal interbody fusion cage

NOVAL 5° - 04047844009956

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, angled
In Commercial Distribution

  • 04047844009956 ()

  • 12x15x48mm
NV051248

  • Polymeric spinal interbody fusion cage

NOVAL 5° - 04047844009932

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, angled
In Commercial Distribution

  • 04047844009932 ()

  • 9x15x48mm
NV050948

  • Polymeric spinal interbody fusion cage

NOVAL 5° - 04047844009918

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, angled
In Commercial Distribution

  • 04047844009918 ()

  • 16x15x44mm
NV051644

  • Polymeric spinal interbody fusion cage

NOVAL 5° - 04047844009895

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, angled
In Commercial Distribution

  • 04047844009895 ()

  • 12x15x44mm
NV051244

  • Polymeric spinal interbody fusion cage

NOVAL 5° - 04047844009871

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, angled
In Commercial Distribution

  • 04047844009871 ()

  • 9x15x44mm
NV050944

  • Polymeric spinal interbody fusion cage

ALLO-3D-.5 - 00841336100251

0.5cc AlloSculpt-3D Cortical Putty With Chips
SALVIN DENTAL SPECIALTIES, LLC
Rev A
In Commercial Distribution

  • 00841336100251 ()


  • Bone matrix implant, human-derived

CAPNOSTAT 5 - 07325710004180

No Description
Maquet Critical Care AB
6882078
In Commercial Distribution

  • 07325710004180 ()


  • Neonatal/adult intensive-care ventilator

CAAS 5 - 08056304451132

No Description
Pie Medical Imaging B.V.
5.0
In Commercial Distribution

  • 08056304451132 ()


  • Radiology DICOM image processing application software

daVinci 5 - 00886874124017

CO2 Supply Tank Interface Device
INTUITIVE SURGICAL, INC.
380440
In Commercial Distribution

  • 00886874124017 ()


  • Surgical irrigation/aspiration tubing set

daVinci 5 - 00886874123997

BLUE SYSTEM CABLE
INTUITIVE SURGICAL, INC.
399148
In Commercial Distribution

  • 00886874123997 ()


  • Electrical-only medical device connection cable, reusable

daVinci 5 - 00886874119747

Surgeon Side Cart
INTUITIVE SURGICAL, INC.
380730
In Commercial Distribution

  • 00886874119747 ()


  • Robotic surgical arm system

daVinci 5 - 00886874119716

Patient Side Cart
INTUITIVE SURGICAL, INC.
380747
In Commercial Distribution

  • 00886874119716 ()


  • Robotic surgical arm system

daVinci 5 - 00886874119662

Vision Side Cart
INTUITIVE SURGICAL, INC.
380746
In Commercial Distribution

  • 00886874119662 ()


  • Robotic surgical arm system

ACTICOAT 3 5" X 5" - 00040565122045

Silver-coated antimicrobial barrier dressing
SMITH & NEPHEW MEDICAL LIMITED
20151
In Commercial Distribution

  • 00040565122052 ()
  • 00040565122045 ()
  • 30040565122053 ()
20151

  • Wound-nonadherent dressing, absorbent, antimicrobial

ARROW - 30801902093951

AutoCAT2WAVE(R) IABP, Refurbished
TELEFLEX INCORPORATED
IPN001096
In Commercial Distribution

  • 30801902093951 ()
  • 00801902093950 ()
IAP-0500IX

  • Intra-aortic balloon pump

ARROW - 30801902093944

AutoCAT2WAVE(R) IABP, Refurbished
TELEFLEX INCORPORATED
IPN001095
In Commercial Distribution

  • 30801902093944 ()
  • 00801902093943 ()
IAP-0500FX

  • Intra-aortic balloon pump

ARROW - 30801902093913

AutoCAT2WAVE(R) IABP, Refurbished
TELEFLEX INCORPORATED
IPN000328
In Commercial Distribution

  • 30801902093913 ()
  • 00801902093912 ()
IAP-0500X

  • Intra-aortic balloon pump

ARROW - 30801902093753

AutoCAT(R)2 IABP, Refurbished
TELEFLEX INCORPORATED
IPN000311
In Commercial Distribution

  • 30801902093753 ()
  • 00801902093752 ()
IAP-0400X

  • Intra-aortic balloon pump

ARROW - 30801902092190

AUTOCAT2 WAVE ITALIAN
TELEFLEX INCORPORATED
IPN000324
In Commercial Distribution

  • 30801902092190 ()
  • 00801902092199 ()
IAP-0500I

  • Intra-aortic balloon pump

ARROW - 30801902092183

AUTOCAT2 WAVE FRENCH
TELEFLEX INCORPORATED
IPN000323
In Commercial Distribution

  • 30801902092183 ()
  • 00801902092182 ()
IAP-0500F

  • Intra-aortic balloon pump

ARROW - 30801902092176

AUTOCAT2 WAVE GERMAN
TELEFLEX INCORPORATED
IPN000321
In Commercial Distribution

  • 30801902092176 ()
  • 00801902092175 ()
IAP-0500D

  • Intra-aortic balloon pump

ARROW - 30801902092169

AUTOCAT2 WAVE SPANISH
TELEFLEX INCORPORATED
IPN000322
In Commercial Distribution

  • 30801902092169 ()
  • 00801902092168 ()
IAP-0500E

  • Intra-aortic balloon pump

ARROW - 30801902092152

AEROAUTOCAT2 SWEDISH
TELEFLEX INCORPORATED
IPN000319
In Commercial Distribution

  • 30801902092152 ()
  • 00801902092151 ()
IAP-0435SV

  • Intra-aortic balloon pump
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