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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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U2 Stem, quick connect holder
UNITED ORTHOPEDIC CORP.
9104-1214
In Commercial Distribution

  • 04719872171669 ()
9104-1214

  • Orthopaedic inorganic implant inserter/extractor, reusable
DRIVER EX0411006 LONG SCREW ADJUSTMENT
MEDTRONIC SOFAMOR DANEK, INC.
EX0411006
In Commercial Distribution

  • 00613994992642 ()


  • Orthopaedic implant driver
CONICAL ABUT HX 4HD 1CH 4.5CW W/SCREW #19509001 TI USE 2MM INTERNAL HEX DRIVER
ACE SURGICAL SUPPLY CO., INC.
01409011
In Commercial Distribution

  • 00614950003693 ()

  • Width: 4.5 Millimeter
01409011

  • Screw endosteal dental implant, one-piece
DRIVER, SET SCREW
Pioneer Surgical Technology, Inc.
23-SETSCREWINS
Not in Commercial Distribution

  • 00846468027490 ()


  • General internal orthopaedic fixation system implantation kit
NUT DRIVER
Pioneer Surgical Technology, Inc.
23-NUTDRIVER
Not in Commercial Distribution

  • 00846468027391 ()


  • General internal orthopaedic fixation system implantation kit
SET SCREW FINAL DRIVER
Pioneer Surgical Technology, Inc.
23-FINALDRIVER
Not in Commercial Distribution

  • 00846468027292 ()
23-FINALDRIVER

  • Spinal bone screw, non-bioabsorbable
STAR DRIVER
TORNIER, INC.
AFPSDRIV
Not in Commercial Distribution

  • 00846832016532 ()
AFPSDRIV

  • Surgical screwdriver, reusable
SLOTTED MALLET
TORNIER, INC.
9722938
In Commercial Distribution

  • 00846832016013 ()
9722938

  • Surgical mallet
TORQUE LIMITING DRIVER
TORNIER, INC.
9030391
In Commercial Distribution

  • 00846832015511 ()
9030391

  • Surgical instrument handle, torque-limiting
TORQUE DRIVER HANDLE
TORNIER, INC.
9030115
In Commercial Distribution

  • 00846832015092 ()
9030115

  • Surgical instrument handle, non-torque-limiting
HEX SCREW DRIVER BIT
TORNIER, INC.
9030110
In Commercial Distribution

  • 00846832015085 ()

  • Outer Diameter: 3.5 Millimeter
9030110

  • Surgical screwdriver, reusable
TORQUE SCREWDRIVER ADAPTATOR
TORNIER, INC.
MKY122
In Commercial Distribution

  • 00846832013449 ()
MKY122

  • Surgical screwdriver, reusable
ASSY,MODULE,ISI2,CORE (89302900)
Bayer Medical Care Inc.
ISI2
In Commercial Distribution

  • 00616258027340 ()
ISI2

  • CT contrast medium injection system, line-powered, mobile
No Description
Bayer Medical Care Inc.
SCT-310, SCT-321, SCT-322
In Commercial Distribution

  • 00616258025131 ()
SCT-310, SCT-321, SCT-322

  • CT contrast medium injection system, line-powered, mobile
SYSTEM,INJECTOR,MRXPERION,CORE,LR (87838420)
Bayer Medical Care Inc.
MRXP 200
In Commercial Distribution

MRXP 200

  • MRI contrast medium injection system, line-powered, mobile
#8 STAR SCREW DRIVER BIT
TORNIER, INC.
7000002
In Commercial Distribution

  • 00846832004683 ()
7000002

  • Surgical screwdriver, reusable
HEX SCREW DRIVER BIT
TORNIER, INC.
7000001
In Commercial Distribution

  • 00846832004676 ()

  • Outer Diameter: 2.5 Millimeter
7000001

  • Surgical screwdriver, reusable
SYSTEM,INJECTOR,MRXPERION (86410036)
BAYER MEDICAL CARE INC.
MRXperion
In Commercial Distribution

  • 00616258021355 ()
MRXP 200

  • MRI contrast medium injection system, line-powered, mobile
CT – STELLANT D DUAL INJECTOR, UPGRADED (86184524)
BAYER MEDICAL CARE INC.
Stellant D
In Commercial Distribution

  • 00616258021348 ()
SCT-210, SCT-211, SCT-212, SCT-221, SCT-222

  • CT contrast medium injection system, line-powered, mobile
DUAL,STELLANT W/CERTEGRA WKS, UPGRADED (86184516)
BAYER MEDICAL CARE INC.
Stellant D-CE
In Commercial Distribution

  • 00616258021331 ()
SCT-310, SCT-321, SCT-322

  • CT contrast medium injection system, line-powered, mobile
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
AO RATCHETING DRIVER HANDLE
TORNIER, INC.
AFPDRAO
Not in Commercial Distribution

  • 00846832000951 ()
AFPDRAO

  • Surgical instrument handle, non-torque-limiting
CLARITY II, T-HANDLE DRIVER
Pioneer Surgical Technology, Inc.
725-130
Not in Commercial Distribution

  • 00846468099510 ()
725-130

  • Surgical retraction system, reusable
MAINTAINER,SYR HEAT,STEL,PFS,LR (88457285)
BAYER MEDICAL CARE INC.
SSH 100F
In Commercial Distribution

  • 00616258026473 ()
SSH 100F

  • CT contrast medium injection system, line-powered, mobile
MAINTAIN,SYR HEAT,STELL,FLS2,LR (87980030)
BAYER MEDICAL CARE INC.
SSH 200F
In Commercial Distribution

  • 00616258025384 ()
SSH 200F

  • CT contrast medium injection system, line-powered, mobile
ASSY, Module, ISI2 (86882302)
Bayer Medical Care Inc.
ISI2
In Commercial Distribution

  • 00616258022512 ()
ISI2

  • CT contrast medium injection system, line-powered, mobile
STELLANT,SYS,INJ,D SYR,W/CERT WKS,MC,4ED (85937286)
BAYER MEDICAL CARE INC.
Stellant D-CE
In Commercial Distribution

  • 00616258020860 ()
SCT-310, SCT-321, SCT-322

  • CT contrast medium injection system, line-powered, mobile
STELLANT,SYS,INJ,D,DUAL SYR,LATAM2,4ED (85920278)
BAYER MEDICAL CARE INC.
Stellant D-CE
In Commercial Distribution

  • 00616258020822 ()
SCT-310, SCT-321, SCT-322

  • CT contrast medium injection system, line-powered, mobile
SYSTEM,DUAL,STELLANT,REMANUFACTURED,FLEX (85631829)
BAYER MEDICAL CARE INC.
Stellant FLEX
In Commercial Distribution

  • 00616258020792 ()
FLEX UPG

  • CT contrast medium injection system, line-powered, mobile
MAINTAIN,SYR HEAT,STEL,FLS2,UDI,BATCH,JA (85864483)
BAYER MEDICAL CARE INC.
SSH 200F
In Commercial Distribution

  • 00616258020662 ()
SSH 200F

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