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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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CGS Driver 4mm Square Drive Converter
BIOHORIZONS IMPLANT SYSTEMS, INC
CGS-4SC
In Commercial Distribution

  • 00847236011208 ()
  • 00847236019396 ()


  • Surgical screwdriver, reusable
CGS Retained Implant-level Driver 3.8mm, 3.0mm Platform
BIOHORIZONS IMPLANT SYSTEMS, INC
CGS-TP3IDR
In Commercial Distribution

  • 00847236011154 ()


  • Surgical screwdriver, reusable
CGS Retained Implant-level Driver 3.8mm
BIOHORIZONS IMPLANT SYSTEMS, INC
CGS-PYIDR
In Commercial Distribution

  • 00847236011147 ()


  • Surgical screwdriver, reusable
CGS Retained Implant-level Driver 4.6mm, 3.5mm Platform
BIOHORIZONS IMPLANT SYSTEMS, INC
CGS-PYGIDR
In Commercial Distribution

  • 00847236011130 ()


  • Surgical screwdriver, reusable
CGS Retained Implant-level Driver 4.6mm
BIOHORIZONS IMPLANT SYSTEMS, INC
CGS-PGIDR
In Commercial Distribution

  • 00847236011123 ()


  • Surgical screwdriver, reusable
CGS Retained Implant-level Driver 5.8mm, 4.5mm Platform
BIOHORIZONS IMPLANT SYSTEMS, INC
CGS-PGBIDR
In Commercial Distribution

  • 00847236011116 ()


  • Surgical screwdriver, reusable
CGS Retained Implant-level Driver 5.8mm
BIOHORIZONS IMPLANT SYSTEMS, INC
CGS-PBIDR
In Commercial Distribution

  • 00847236011109 ()


  • Surgical screwdriver, reusable
HD Implant-level Driver, Handpiece, 3.5/4.5mm
BIOHORIZONS IMPLANT SYSTEMS, INC
TYGIDH
In Commercial Distribution

  • 00847236011093 ()
  • 00847236021337 ()


  • Surgical screwdriver, reusable
HD Implant-level Driver, Ratchet, 3.5/4.5mm
BIOHORIZONS IMPLANT SYSTEMS, INC
TYGIDR
In Commercial Distribution

  • 00847236011086 ()


  • Surgical screwdriver, reusable
HD Implant-level Driver, Handpiece, 5.7mm
BIOHORIZONS IMPLANT SYSTEMS, INC
TBIDH
In Commercial Distribution

  • 00847236011079 ()
  • 00847236020200 ()


  • Surgical screwdriver, reusable
HD Implant-level Driver, Ratchet, 5.7mm
BIOHORIZONS IMPLANT SYSTEMS, INC
TBIDR
In Commercial Distribution

  • 00847236011062 ()


  • Surgical screwdriver, reusable
Slide Hammer
INTAI TECHNOLOGY CORP.
INS-SLDHMR
In Commercial Distribution

  • 04719894320069 ()


  • Surgical mallet
Intraosseous Fixation Peek Implant & Driver Assembly
TORNIER, INC.
IFP-010-29
Not in Commercial Distribution

  • 00846832035199 ()

  • Outer Diameter: 2.9 Millimeter
  • Length: 8 Millimeter
IFP-010-29

  • Orthopaedic fixation plate, non-bioabsorbable
Intraosseous Fixation Peek Implant & Driver Assembly
TORNIER, INC.
IFP-010-27
Not in Commercial Distribution

  • 00846832035175 ()

  • Outer Diameter: 2.7 Millimeter
  • Length: 7 Millimeter
IFP-010-27

  • Orthopaedic fixation plate, non-bioabsorbable
Intraosseous Fixation Peek Implant & Driver Assembly
TORNIER, INC.
IFP-010-24
Not in Commercial Distribution

  • 00846832035151 ()

  • Length: 7 Millimeter
  • Outer Diameter: 2.4 Millimeter
IFP-010-24

  • Orthopaedic fixation plate, non-bioabsorbable
Intraosseous Fixation Peek Implant & Driver Assembly
TORNIER, INC.
IFP-010-22
Not in Commercial Distribution

  • 00846832035137 ()

  • Outer Diameter: 2.2 Millimeter
  • Length: 7 Millimeter
IFP-010-22

  • Orthopaedic fixation plate, non-bioabsorbable
ZP™ SOLID HEX DRIVER
TORNIER, INC.
HCS-056-38S
In Commercial Distribution

  • 00846832034536 ()

  • Outer Diameter: 2 Millimeter
  • Size For Ø3.8mm Screws
HCS-056-38S

  • Surgical screwdriver, reusable
ZP™ CANNULATED HEX DRIVER
TORNIER, INC.
HCS-056-38
In Commercial Distribution

  • 00846832034529 ()

  • Size For Ø3.8mm Screws
  • Outer Diameter: 2 Millimeter
HCS-056-38

  • Surgical screwdriver, reusable
ZP™ SOLID HEX DRIVER
TORNIER, INC.
HCS-056-32S
In Commercial Distribution

  • 00846832034512 ()

  • Size For Ø3.2mm Screws
  • Outer Diameter: 2 Millimeter
HCS-056-32S

  • Surgical screwdriver, reusable
ZP™ CANNULATED HEX DRIVER
TORNIER, INC.
HCS-056-32
In Commercial Distribution

  • 00846832034505 ()

  • Size For Ø3.2mm Screws
  • Outer Diameter: 2 Millimeter
HCS-056-32

  • Surgical screwdriver, reusable
CLX DRIVER
TORNIER, INC.
CLX-056T
In Commercial Distribution

  • 00846832028511 ()
CLX-056T

  • Surgical screwdriver, reusable
HEX DRIVER
TORNIER, INC.
SH0797
In Commercial Distribution

  • 00846832026258 ()
SH0797

  • Surgical screwdriver, reusable
PROXIMAL SCREWDRIVER
TORNIER, INC.
9020170
In Commercial Distribution

  • 00846832026234 ()
9020170

  • Surgical screwdriver, reusable
Injector-Scanner Interface, ISI-900H Module(MODULE, HITACHI, ISI 900H)(84819484)
BAYER MEDICAL CARE INC.
ISI 900H
In Commercial Distribution

  • 00616258009766 ()
ISI 900H

  • CT contrast medium injection system, line-powered, mobile
REFURBISHED SYSTEM,DUAL SYR,STELLANT D, MC (60728095)
BAYER MEDICAL CARE INC.
Stellant D
In Commercial Distribution

  • 00616258008981 ()
SCT211-R, SCT212-R, SCT221-R, SCT222-R

  • CT contrast medium injection system, line-powered, mobile
REFURBISHED SYSTEM,SNGL SYR,STELLANT SX, MC (60728087)
BAYER MEDICAL CARE INC.
Stellant Sx
In Commercial Distribution

  • 00616258008974 ()
SCT121-R, SCT122-R

  • CT contrast medium injection system, line-powered, mobile
"SYSTEM,DUAL SYRINGE,STELLANT,901,MC (84334154)"
BAYER MEDICAL CARE INC.
Stellant D
In Commercial Distribution

  • 00616258008967 ()
SCT-210, SCT-211, SCT-212, SCT-221, SCT-222

  • CT contrast medium injection system, line-powered, mobile
"ASSY, KIT, STELLANT MOBILE,MC (60766175)"
BAYER MEDICAL CARE INC.
SCT 211P
In Commercial Distribution

  • 00616258008950 ()
SCT 211P

  • CT contrast medium injection system, line-powered, mobile
"DUAL STELLANT W/CERTEGRA WKS (60726807)"
BAYER MEDICAL CARE INC.
Stellant D-CE
In Commercial Distribution

  • 00616258008943 ()
SCT-310, SCT-321, SCT-322

  • CT contrast medium injection system, line-powered, mobile
"CT - STELLANT D DUAL INJECTOR,MC (60726726)"
BAYER MEDICAL CARE INC.
Stellant D
In Commercial Distribution

  • 00616258008912 ()
SCT-210, SCT-211, SCT-212, SCT-221, SCT-222

  • CT contrast medium injection system, line-powered, mobile
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