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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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Invacare® TDXSP2-HD with Captains Seat - 00841447102052

TDXSP2-HD with Captain's Seat
INVACARE CORPORATION
TDXSP2V-HD
In Commercial Distribution

  • 00841447102052 ()

  • Adult/Bariatric


  • Electric-motor-driven wheelchair, occupant-controlled

Clam-Lok™ Cushion - 00841439112113

Nylon bag with indexing
MEDTEC, INC.
VLSBRT202FC
In Commercial Distribution

  • 00841439112113 ()
VLSBRT202FC

  • Vacuum-mould patient positioning system

C-Qual™ - 00841439110720

Breastboard with head support
MEDTEC, INC.
MT402
In Commercial Distribution

  • 00841439110720 ()

  • Length: 50.8 Inch
MT402

  • Radiological breast positioner, non-wearable

Type-S™ Extension - 00841439104156

For use with Varian
MEDTEC, INC.
MTCFHNV
In Commercial Distribution

  • 00841439104156 ()
MTCFHNV

  • Indexed-immobilization patient positioning system

Precise Bite™ - 00841439104088

Mouthpiece with tongue depressor
MEDTEC, INC.
MTCBPBITETD
In Commercial Distribution

  • 00841439104088 ()
  • 10841439104085 ()
MTCBPBITETD

  • Radiological head/neck positioning mouthpiece

Prone Head Holder - 00841439102466

with gel pads (2)
MEDTEC, INC.
MT202
In Commercial Distribution

  • 00841439102466 ()

  • Width: 10 Inch
  • Length: 12 Inch
MT202

  • Patient positioner base plate

Shoulder Retractors - 00841439102169

with wool wrist strap
MEDTEC, INC.
20SR02SUB2
In Commercial Distribution

  • 00841439102169 ()

  • Length: 57.1 Inch
20SR02SUB2

  • Radiological arm/leg positioner

NA - 10886982193711

CANNULATED AWL WITH T-HANDLE
SYNTHES (U.S.A.) LP
351.12
Not in Commercial Distribution

  • H6793511206 ()
  • 10886982193711 ()
35112

  • Bone awl, reusable

NA - 10886982187413

T-HANDLE WITH QUICK COUPLING
Synthes GmbH
311.44
In Commercial Distribution

  • H679311440 ()
  • 10886982187413 ()
31144

  • Surgical instrument handle, non-torque-limiting

NA - 10886982187086

SMALL CHUCK WITH KEY
SYNTHES (U.S.A.) LP
310.93
In Commercial Distribution

  • H679310930 ()
  • 10886982187086 ()
31093

  • Surgical drill chuck

n.a. - 04048551364970

Palpation Probe with cm-marking
Karl Storz GmbH & Co. KG
26167TNS
In Commercial Distribution

  • 04048551364970 ()
26167TNS

  • Endoscopic surgical probe

n.a. - 04048551364963

Palpation Probe with cm-markings
Karl Storz GmbH & Co. KG
26167TNL
In Commercial Distribution

  • 04048551364963 ()
26167TNL

  • Endoscopic surgical probe

n.a. - 04048551359730

Trocar, with conical-blunt tip
Karl Storz GmbH & Co. KG
30103NG
In Commercial Distribution

  • 04048551359730 ()


  • Laparoscopic trocar blade, reusable

n.a. - 04048551359723

Trocar, with conical-blunt tip
Karl Storz GmbH & Co. KG
30160NS
In Commercial Distribution

  • 04048551359723 ()


  • Laparoscopic trocar blade, reusable

n.a. - 04048551359716

Trocar, with conical-blunt tip
Karl Storz GmbH & Co. KG
30160NG
In Commercial Distribution

  • 04048551359716 ()


  • Laparoscopic trocar blade, reusable

n.a. - 04048551359709

Trocar, with conical tip
Karl Storz GmbH & Co. KG
30103YG
In Commercial Distribution

  • 04048551359709 ()


  • Laparoscopic trocar blade, reusable

n.a. - 04048551359693

Trocar, with conical tip
Karl Storz GmbH & Co. KG
30108YG
In Commercial Distribution

  • 04048551359693 ()


  • Laparoscopic trocar blade, reusable

n.a. - 04048551359686

Trocar, with conical-blunt tip
Karl Storz GmbH & Co. KG
30114NS
In Commercial Distribution

  • 04048551359686 ()


  • Laparoscopic trocar blade, reusable

n.a. - 04048551359655

Trocar, with pyramidal tip
Karl Storz GmbH & Co. KG
30108ZG
In Commercial Distribution

  • 04048551359655 ()


  • Laparoscopic trocar blade, reusable

n.a. - 04048551359648

Trocar, with conical tip
Karl Storz GmbH & Co. KG
30114YG
In Commercial Distribution

  • 04048551359648 ()


  • Laparoscopic trocar blade, reusable

n.a. - 04048551359631

Trocar, with conical tip
Karl Storz GmbH & Co. KG
30114YS
In Commercial Distribution

  • 04048551359631 ()


  • Laparoscopic trocar blade, reusable

n.a. - 04048551359624

Trocar, with conical-blunt tip
Karl Storz GmbH & Co. KG
30114NG
In Commercial Distribution

  • 04048551359624 ()


  • Laparoscopic trocar blade, reusable

n.a. - 04048551359617

Trocar, with pyramidal tip
Karl Storz GmbH & Co. KG
30160ZS
In Commercial Distribution

  • 04048551359617 ()


  • Laparoscopic trocar blade, reusable

n.a. - 04048551359587

Trocar, with pyramidal tip
Karl Storz GmbH & Co. KG
30114ZG
In Commercial Distribution

  • 04048551359587 ()


  • Laparoscopic trocar blade, reusable

n.a. - 04048551359570

Trocar with pyramidal tip
Karl Storz GmbH & Co. KG
30114ZS
In Commercial Distribution

  • 04048551359570 ()


  • Laparoscopic trocar blade, reusable

n.a. - 04048551359563

Trocar with pyramidal tip
Karl Storz GmbH & Co. KG
11603ZS
In Commercial Distribution

  • 04048551359563 ()


  • Laparoscopic trocar blade, reusable

n.a. - 04048551306222

trocar with blunt tip
Karl Storz GmbH & Co. KG
30114AX
In Commercial Distribution

  • 04048551306222 ()


  • Laparoscopic trocar blade, reusable

n.a. - 04048551265413

Optic-Lock plug with LUER-Lock
Karl Storz GmbH & Co. KG
26040BX
In Commercial Distribution

  • 04048551265413 ()


  • Endoscope assembly adaptor

CLICKLINE - 04048551265147

Metal Handle, with ratchet
Karl Storz GmbH & Co. KG
33141P
In Commercial Distribution

  • 04048551265147 ()


  • Surgical instrument handle, non-torque-limiting

n.a. - 04048551254776

Trocar, with pyramidal tip
Karl Storz GmbH & Co. KG
30114C
In Commercial Distribution

  • 04048551254776 ()


  • Laparoscopic trocar blade, reusable

n.a. - 04048551196311

Rod, with 4 rings
Karl Storz GmbH & Co. KG
745201
In Commercial Distribution

  • 04048551196311 ()


  • Surgical instrument assist arm system, manually-adjusted

Tecomet - 00841435108226

ARTHROPASSER STRAIGHT WITH LOCK
TECOMET INC.
910074
In Commercial Distribution

  • 00841435108226 ()


  • Arthroscopic suturing unit

NA - 10886982307293

HANDLE WITH HEX COUPLING
Synthes GmbH
SD311.008
In Commercial Distribution

  • 10886982307293 ()
SD311008

  • Surgical instrument handle, non-torque-limiting

Kyocera Medical Technologies, Inc. - 00841523121649

Awl with Universal Joint
KYOCERA MEDICAL TECHNOLOGIES, INC.
S 128
In Commercial Distribution

  • 00841523121649 ()
2128-001-012

  • General internal orthopaedic fixation system implantation kit

CARDINAL HEALTH - 10887488151441

PPE KIT WITH COVERALLS
Cardinal Health 200, LLC
ISO99PPEWC
In Commercial Distribution

  • 50887488151449 ()
  • 10887488151441 ()
ISO99PPEWC

  • General surgical procedure kit, non-medicated, single-use

Tissue-Tek® SmartWrite® - 00615233082374

Cassette Printer with AutoLoader
SAKURA FINETEK U.S.A., INC.
9020
In Commercial Distribution

  • 00615233082374 ()
9020

  • Cell morphology analyser IVD, automated/semi-automated
  • Computed radiography digital imaging scanner

MicroAire® - 00847399003775

ELECTRIC MOTOR WITH THROTTLE
Microaire Surgical Instruments LLC
5000ET
In Commercial Distribution

  • 00847399003775 ()


  • Surgical power tool system control unit, line-powered

Tissue-Tek Film® - 00615233078827

Coverslipper with Barcode Reader
SAKURA FINETEK U.S.A., INC.
4743
In Commercial Distribution

  • 00615233078827 ()
4743

  • Barcode reader
  • Microscope slide coverslipper IVD

TEHLIN - 04719883460523

L-BRACKET, STEEL WITH EXTENSIONS
TEH LIN PROSTHETIC & ORTHOPAEDIC INC.
D-TSC-KD-L
In Commercial Distribution

  • 04719883460523 ()


  • External lower-limb prosthesis structural/alignment component

“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile) - 04719878786881

Awl with Depth Stop
Paonan Biotech Co.,Ltd.
406-0201
In Commercial Distribution

  • 04719878786881 ()
406-0201

  • Bone awl, reusable

WatchTower - 04719876737267

Spine Clamp with DRF
INTAI TECHNOLOGY CORP.
NAVTL0002
In Commercial Distribution

  • 04719876737267 ()


  • Orthopaedic stereotactic surgery system

WatchTower - 04719876732323

Spine pin with DRF
INTAI TECHNOLOGY CORP.
INS-REFPIN
In Commercial Distribution

  • 04719876732323 ()


  • Orthopaedic stereotactic surgery system

Compression Staple System - 00846832055944

INSERTER ASSEMBLY WITH LOCK
TORNIER, INC.
STP-056-L
In Commercial Distribution

  • 00846832055944 ()
STP-056-L

  • Surgical implant/trial-implant/sizer holder, reusable

CARDINAL HEALTH - 10888439810608

KIT, RECOVERY WITH PILLOW
Cardinal Health 200, LLC
OMS4401328
In Commercial Distribution

  • 50888439810606 ()
  • 10888439810608 ()
OMS4401328

  • General surgical procedure kit, non-medicated, single-use

MEDLINE - 10193489194470

PIV KIT WITH SECUREMENT
MEDLINE INDUSTRIES, INC.
DYNDV2236A
In Commercial Distribution

  • 20193489194477 ()
  • 10193489194470 ()
DYNDV2236A

  • Peripheral intravenous catheterization support kit

CARDINAL HEALTH - 10888439746341

MINOR BASIN WITH GOWN
Cardinal Health 200, LLC
SBA22MBGC1
In Commercial Distribution

  • 50888439746349 ()
  • 10888439746341 ()
SBA22MBGC1

  • General surgical procedure kit, non-medicated, single-use

Ventilator - 00847946024130

CLAMP WITH DOVETAIL,CCLAW
Zoll Medical Corporation
703-0904-16
In Commercial Distribution

  • 00847946024130 ()


  • Transport electric ventilator

CARDINAL HEALTH - 10888439705409

SCOPE PACK WITH POUCH
Cardinal Health 200, LLC
SOPOCSPNA1
In Commercial Distribution

  • 50888439705407 ()
  • 10888439705409 ()
SOPOCSPNA1

  • Arthroscopic surgical procedure kit, non-medicated, single-use

Dover - 10192253027648

CATHETER PLUG WITH CAP
Cardinal Health 200, LLC
1600
In Commercial Distribution

  • 50192253027646 ()
  • 10192253027648 ()
1600-

  • Intermittent urethral drainage catheter, non-antimicrobial, single-use

PENTAX - 04961333224807

FORCEPS WITH WINDOW/SPIKE
HOYA CORPORATION
KH2430S
Not in Commercial Distribution

  • 04961333224807 ()
  • 04961333136315 ()


  • Open-surgery biopsy forceps, reusable
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