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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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MEDRAD® Stellant Imaging System Interface ISI 700 Module - 00616258008448

"Injector-Scanner Interface, ISI-700 Module (60766256)"
BAYER MEDICAL CARE INC.
ISI 700
In Commercial Distribution

  • 00616258008448 ()
ISI 700

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

MEDRAD XDS Extravasation Detection System - 00616258008189

"CT - EXTRAVASATION DETECTOR SENSOR (60727765)"
BAYER MEDICAL CARE INC.
PSA 700
In Commercial Distribution

  • 00616258008189 ()
PSA 700

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

MEDRAD XDS Extravasation Detection System - 00616258008172

"CT - EXTRAVASATION DETECTOR SYS,NON CE (60727064)"
BAYER MEDICAL CARE INC.
XDS 700
In Commercial Distribution

  • 00616258008172 ()
XDS 700

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

MEDRAD® MRXperion MR Injection System - 00616258008158

"ASSY,POLE,IV,SINGLE HOOK (84284246)"
BAYER MEDICAL CARE INC.
MRXP IV S
In Commercial Distribution

  • 00616258008158 ()
MRXP IV S

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

MEDRAD® MRXperion MR Injection System - 00616258008141

"Assy, IV Pole, MRXperion (84290149)"
BAYER MEDICAL CARE INC.
MRXP IV D
In Commercial Distribution

  • 00616258008141 ()
MRXP IV D

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

MEDRAD® MRXperion MR Injection System - 00616258008134

"SYSTEM,INJECTOR,MRXPERION (84200085)"
BAYER MEDICAL CARE INC.
MRXperion
In Commercial Distribution

  • 00616258008134 ()
MRXP 200

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

Tornier Latitude - 00846832013449

TORQUE SCREWDRIVER ADAPTATOR
TORNIER, INC.
MKY122
In Commercial Distribution

  • 00846832013449 ()
MKY122

  • Surgical screwdriver, reusable

MEDRAD® Stellant CT Injection System - 00616258020860

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

MEDRAD® Stellant CT Injection System - 00616258020822

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

MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation (Upgrade) - 00616258020792

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

MEDRAD® Stellant CT Injection System - 00616258020662

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

MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation - 00616258011219

SYSTEM,DUAL,STELLANT,FLEX (85577026)
BAYER MEDICAL CARE INC.
Stellant FLEX
In Commercial Distribution

  • 00616258011219 ()
FLEX

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

MEDRAD® Stellant CT Injection System - 00616258010588

REFURBISHED SYSTEM,SNGL SYR,STELLANT SX (84856798)
BAYER MEDICAL CARE INC.
SCT121-R, SCT122-R
In Commercial Distribution

  • 00616258010588 ()
SCT121-R, SCT122-R

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

MEDRAD® Stellant CT Injection System - 00616258010571

REFURBISHED SYSTEM,DUAL SYR,STELLANT D (59875705)
BAYER MEDICAL CARE INC.
SCT211-R, SCT212-R, SCT221-R, SCT222-R
In Commercial Distribution

  • 00616258010571 ()
SCT211-R, SCT212-R, SCT221-R, SCT222-R

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

CABLE,HANDSWITCH,20',DCU,UDI,BATCH - 00616258010519

CABLE,HANDSWITCH,20',DCU,UDI,BATCH (85594389)
BAYER MEDICAL CARE INC.
EDS 700 20
In Commercial Distribution

  • 00616258010519 ()
EDS 700 20

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

ASSY,CBL,RPC,MN,SHLD,START,SW,UDI,BATCH - 00616258010502

ASSY,CBL,RPC,MN,SHLD,START,SW,UDI,BATCH (85594370)
BAYER MEDICAL CARE INC.
RPA 550-1
In Commercial Distribution

  • 00616258010502 ()
RPA 550-1

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

CABLE,HANDSWITCH,5',DCU,UDI,BATCH - 00616258010472

CABLE,HANDSWITCH,5',DCU,UDI,BATCH (85594281)
BAYER MEDICAL CARE INC.
EDS 700 05
In Commercial Distribution

  • 00616258010472 ()
EDS 700 05

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

CABLE,START SWITCH,25FT,4PIN,UDI,BATCH - 00616258010441

CABLE,START SWITCH,25FT,4PIN,UDI,BATCH (85594168)
BAYER MEDICAL CARE INC.
RPA 550
In Commercial Distribution

  • 00616258010441 ()
RPA 550

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

MAINTAINER,HEAT,SYR,125/200 ML,UDI,BATCH - 00616258010427

MAINTAINER,HEAT,SYR,125/200 ML,UDI,BATCH (85594133)
BAYER MEDICAL CARE INC.
VSH 600
In Commercial Distribution

  • 00616258010427 ()
VSH 600

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

CBL,HANDSWITCH,20',HEAD,MCT2.0,UDI,BATCH - 00616258010410

CBL,HANDSWITCH,20',HEAD,MCT2.0,UDI,BATCH (85591312)
BAYER MEDICAL CARE INC.
EHS 700 20
In Commercial Distribution

  • 00616258010410 ()
EHS 700 20

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

CBL,HANDSWITCH,5',HEAD,MCT2.0,UDI,BATCH - 00616258010403

CBL,HANDSWITCH,5',HEAD,MCT2.0,UDI,BATCH (85591304)
BAYER MEDICAL CARE INC.
EHS 700 05
In Commercial Distribution

  • 00616258010403 ()
EHS 700 05

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

MAINTAIN,SYRINGE HEAT,ENVISION,UDI,BATCH - 00616258010397

MAINTAIN,SYRINGE HEAT,ENVISION,UDI,BATCH (85591290)
BAYER MEDICAL CARE INC.
ESH 700
In Commercial Distribution

  • 00616258010397 ()
ESH 700

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

MEDRAD® Stellant CT Injection System - 00616258010250

SYSTEM,DUAL,STELLANT D,COUNTRY SPECIFIC (85077198)
BAYER MEDICAL CARE INC.
Stellant D
In Commercial Distribution

  • 00616258010250 ()
SCT-210, SCT-211, SCT-212, SCT-221, SCT-222

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

MEDRAD® Stellant CT Injection System - 00616258010243

SYSTEM STELLANT SX, COUNTRY SPECIFIC (85073052)
BAYER MEDICAL CARE INC.
Stellant SX
In Commercial Distribution

  • 00616258010243 ()
SCT-110, SCT-111, SCT-112, SCT-120, SCT-121, SCT-122

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

CLARITY RETRACTOR SYSTEM - 00846468099510

CLARITY II, T-HANDLE DRIVER
Pioneer Surgical Technology, Inc.
725-130
Not in Commercial Distribution

  • 00846468099510 ()
725-130

  • Surgical retraction system, reusable

CLARITY RETRACTOR SYSTEM - 00846468098582

DRIVER
Pioneer Surgical Technology, Inc.
09-DRIVER
Not in Commercial Distribution

09-DRIVER

  • Surgical screwdriver, reusable

“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile) - 04719884699120

Torx Screw Driver T15
Paonan Biotech Co.,Ltd.
428-4330
In Commercial Distribution

  • 04719884699120 ()
428-4330

  • Surgical screwdriver, reusable

“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile) - 04719884698994

T2 Cannulated Screw Driver
Paonan Biotech Co.,Ltd.
TR2-0804C
In Commercial Distribution

  • 04719884698994 ()
TR2-0804C

  • Surgical screwdriver, reusable

Orthopedic manual surgical instrument - 04719883858610

5mm Hex Screw Driver(initial tightening)
BAUI BIOTECH CO. LTD.
409-0829K
In Commercial Distribution

  • 04719883858610 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

U2 Total Knee System - 04719886893953

Screw driver bit, T30
UNITED ORTHOPEDIC CORP.
9404-5105
In Commercial Distribution

  • 04719886893953 ()
9404-5105

  • Surgical screwdriver, reusable

U2 Total Knee System - 04719886893618

Screw driver adaptor, T20
UNITED ORTHOPEDIC CORP.
9403-5331-RB
In Commercial Distribution

  • 04719886893618 ()
9403-5331-RB

  • Surgical screwdriver, reusable

U2 Total Knee System - 04719886893441

Tibial baseplate driver
UNITED ORTHOPEDIC CORP.
9403-5101-RJ
In Commercial Distribution

  • 04719886893441 ()
9403-5101-RJ

  • Orthopaedic inorganic implant inserter/extractor, reusable

DM Acetabular System - 04719886893229

Cup positioner, offset
UNITED ORTHOPEDIC CORP.
9207-1303-RA
In Commercial Distribution

  • 04719886893229 ()
9207-1303-RA

  • Orthopaedic inorganic implant inserter/extractor, reusable

U2 Total Knee System - 04719886893069

Tibial baseplate driver
UNITED ORTHOPEDIC CORP.
9403-5101-RH
In Commercial Distribution

  • 04719886893069 ()
9403-5101-RH

  • Orthopaedic inorganic implant inserter/extractor, reusable

U2 Total Knee System - 04719886891997

Ortho mallet
UNITED ORTHOPEDIC CORP.
9304-5104-RA
In Commercial Distribution

  • 04719886891997 ()
9304-5104-RA

  • Surgical mallet

DM Acetabular System - 04719886890808

Cup positioner, offset
UNITED ORTHOPEDIC CORP.
9207-1303-TA
In Commercial Distribution

  • 04719886890808 ()
9207-1303-TA

  • Orthopaedic inorganic implant inserter/extractor, reusable

Orthopedic manual surgical instrument - 04719883337429

5mm Hex Simple Screw Driver(double-sided)
BAUI BIOTECH CO. LTD.
409-0815B
In Commercial Distribution

  • 04719883337429 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

WatchTower - 04719883200464

Hex Key#3 Driver
INTAI TECHNOLOGY CORP.
INS-DRIVER-B
In Commercial Distribution

  • 04719883200464 ()


  • Orthopaedic stereotactic surgery system

WatchTower - 04719883200457

Threaded Fixation Pin Driver
INTAI TECHNOLOGY CORP.
INS-DRIVER-A
In Commercial Distribution

  • 04719883200457 ()


  • Orthopaedic stereotactic surgery system

U-Motion II - 04719886891034

Universal screw driver
UNITED ORTHOPEDIC CORP.
9206-1114-RA
In Commercial Distribution

  • 04719886891034 ()
9206-1114-RA

  • Surgical screwdriver, reusable
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