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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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UNBRANDED - 00193033027325

No Description
FGX INTERNATIONAL INC.
HARDWARE
In Commercial Distribution

  • 00193033027325 ()


  • Tinted non-prescription spectacles

Axiom - 00840363306162

POSAlinc Adjustable Flip-down Headrest Hardware, 1" Ball Pad Adapter
KI MOBILITY, LLC
Hardware
In Commercial Distribution

  • 00840363306162 ()
18172

  • Wheelchair bracket/mount

RAGNELL SCISSORS - 00192896075436

RAGNELL SCISSORS UNDER MINING SPATULATED CURVED BLADES POWER CUT SILVER
SONTEC INSTRUMENTS, INC.
110-318
In Commercial Distribution

  • 00192896075436 ()

  • Length: 9 Inch
110-318

  • General-purpose surgical scissors, reusable

CloudCath Sensor (Sensing Hardware) - 00860006810283

Sensing Hardware
Gastroklenz Inc.
01PD001
In Commercial Distribution

  • 00860006810214 ()
  • 00860006810283 ()


  • Peritoneal dialysis system

eZ-Fix Tool - 00841132180686

Statix Hardware
ORTHOPEDIATRICS CORP.
XFX-625-12L
In Commercial Distribution

  • 00841132180686 ()
XFX-625-12L

  • Surgical traction tensioner connector

eZ-Fix Tool - 00841132180679

Statix Hardware
ORTHOPEDIATRICS CORP.
XFX-625
In Commercial Distribution

  • 00841132180679 ()
XFX-625

  • Surgical traction tensioner

External Fixation - 00190837033897

Hardware Caddy
Life Spine, Inc.
114-385
In Commercial Distribution

  • 00190837033897 ()
114-385

  • External orthopaedic fixation system, single-use

DuraClip Hardware - 07540147000585

DuraClip hardware (pair) for use with Matrx-Vi and Matrx Kidabra-Vi Base Cushions. Lock/release design used to secure the drop hook hardware to the seat fame.
Motion Concepts Inc
BDC
In Commercial Distribution

  • 07540147000585 ()
BDC

  • Wheelchair back rest positioner

BROSELOW™ - 10190752160262

ALS REPLACEMENT HARDWARE
VYAIRE MEDICAL, INC.
7730POCH
In Commercial Distribution

  • 10190752160262 ()
7730POCH

  • First aid kit, non-medicated, reusable

BROSELOW™ - 10889483589236

ALS REPLACEMENT HARDWARE
AIRLIFE
7730POCH
In Commercial Distribution

  • 30889483589230 ()
  • 10889483589236 ()
  • 10190752160262 ()
7730POCH

  • First aid kit, non-medicated, reusable

Revolution External Plating System - 00854641008082

Instrument + Hardware Tray
Metalogix
900126-F
In Commercial Distribution

  • 00854641008082 ()

  • Height: 5.5 Inch
  • Length: 20.9 Inch
  • Width: 10.3 Inch


  • External orthopaedic fixation system, reusable

Diagnostic Interface Box II - 09008737044015

Hardware Interface System
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
04401
Not in Commercial Distribution

  • 09008737044015 ()


  • Hearing aid/implant system programming interface unit

Stimulator Box - 09008737370053

Hardware Interface System
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
37005
In Commercial Distribution

  • 09008737370053 ()


  • Nerve location/function operative test pulse generator

MAX Programming Interface Box - 09008737084493

Hardware Interface System
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
08449
In Commercial Distribution

  • 09008737084493 ()


  • Hearing aid/implant system programming interface unit

PULSE - 00195377052421

PULSE Inserter, Hardware
Nuvasive, Inc.
5050300
In Commercial Distribution

  • 00195377052421 ()


  • Orthopaedic stereotactic surgery system

ACS - 00191072009128

HARDWARE REMOVAL PACK
AMERICAN CONTRACT SYSTEMS, INC.
NERE40C
In Commercial Distribution

  • 00191072009128 ()


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

Vilex Tool - 00841132180617

Strut & Hardware Tray
ORTHOPEDIATRICS CORP.
RFX-200
In Commercial Distribution

  • 00841132180617 ()
RFX-200

  • Instrument tray, reusable

ACS - 00191072054814

HARDWARE REMOVAL PACK
AMERICAN CONTRACT SYSTEMS, INC.
NERE40D
In Commercial Distribution

  • 00191072054814 ()


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

CRW® - 10381780251934

CRW-PBS HARDWARE KIT
INTEGRA LIFESCIENCES CORPORATION
CRWPBSHK
In Commercial Distribution

  • M433CRWPBSHK1 ()
  • 10381780251934 ()


  • Stereotactic radiosurgical invasive head frame

Campbell Posture - 06973085840004

No Description
Ningbo Yingda Hardware Co.,Ltd.
KG0520
In Commercial Distribution

  • 06973085840004 ()


  • Single-base walking stick

ACIST HDi® HD IVUS System - 40841716102101

ACI Hardware, HDi System p/n 801085-001 Contents: ACI Hardware
ACIST MEDICAL SYSTEMS, INC.
016375
In Commercial Distribution

  • 40841716102101 ()


  • Cardiovascular ultrasound imaging system

E-Sphyg™ II - 00634782057909

Mounting Plate-9002,w/hardware
AMERICAN DIAGNOSTIC CORP
9002-6
In Commercial Distribution

  • 00634782057909 ()
9002-6

  • Blood pressure cuff, reusable

DIB II Coil i100 - 09008737043766

Hardware Interface System Coil
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
04376
Not in Commercial Distribution

  • 09008737043766 ()


  • Hearing implant implantable-component tester, postoperative

DIB II Coil - 09008737041434

Hardware Interface System Coil
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
04143
Not in Commercial Distribution

  • 09008737041434 ()


  • Hearing implant implantable-component tester, postoperative

MAX Coil S - 09008737092726

Hardware Interface System Coil
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
09272
In Commercial Distribution

  • 09008737092726 ()


  • Hearing implant implantable-component tester, postoperative

MAX Coil - 09008737092719

Hardware Interface System Coil
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
09271
In Commercial Distribution

  • 09008737092719 ()


  • Hearing implant implantable-component tester, postoperative

ITD - 00840178701466

Wire basket with hardware
Touchpoint Medical, Inc.
CD.06085.799
In Commercial Distribution

  • 00840178701466 ()


  • Electromechanical device/system transport trolley

Specialty Instrument, Hardware Removal Caddy - 00889795141590

Hardware Removal Caddy, Lid
Paragon 28, Inc.
SP99-LID-0001
In Commercial Distribution

  • 00889795141590 ()
SP99-LID-0001

  • Device sterilization/disinfection container, reusable

Specialty Instrument, Hardware Removal Caddy - 00889795141583

Hardware Removal Caddy, Base
Paragon 28, Inc.
SP99-CAD-0001
In Commercial Distribution

  • 00889795141583 ()
SP99-CAD-0001

  • Device sterilization/disinfection container, reusable

Surelock - 00840252901096

HEADREST HARDWARE, SURELOCK MULTI-AXIS.
Therafin Corporation
50218
In Commercial Distribution

  • 00840252901096 ()
50218

  • Wheelchair/chair/stander headrest

Multi-Axis - 00840252901089

HEADREST HARDWARE, MULTI-AXIS OFFSET.
Therafin Corporation
50215
In Commercial Distribution

  • 00840252901089 ()
50215

  • Wheelchair/chair/stander headrest

Orthex External Fixation System - 00840194466103

Ex-Fix Hardware Removal, Tray
ORTHOPEDIATRICS CORP.
01-2200-0202
In Commercial Distribution

  • 00840194466103 ()
01-2200-0202

  • Instrument tray, reusable

Orthex External Fixation System - 00840194466097

Ex-Fix Hardware Removal, Case
ORTHOPEDIATRICS CORP.
01-2200-0201
In Commercial Distribution

  • 00840194466097 ()
01-2200-0201

  • Instrument tray, reusable

Arial - 00840948100888

ASSY, FINAL, WAVEWARE+HARDWARE
Securitas Healthcare LLC
0900-353
In Commercial Distribution

  • 00840948100888 ()
0900-353

  • Phone/pager

CARDINAL HEALTH - 10887488156910

STERILE HARDWARE REMOVAL PACK
Cardinal Health 200, LLC
SOP81HRNEF
In Commercial Distribution

  • 50887488156918 ()
  • 10887488156910 ()
SOP81HRNEF

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

CONMED - 10845854041581

HARDWARE KIT FOR VP8532
Conmed Corporation
VP8567
In Commercial Distribution

  • 10845854041581 ()
VP8567

  • Medical device integration rack

Avalign - 00190776020934

Accessory Box with hardware
Avalign Technologies, Inc.
113-114
In Commercial Distribution

  • 00190776020934 ()

  • Length: 3.5 Inch
  • Length: 1 Inch
  • Width: 1.5 Inch


  • Device sterilization/disinfection container, reusable

Avalign - 00190776020712

Accessory Box with hardware
Avalign Technologies, Inc.
1000-1120-017
In Commercial Distribution

  • 00190776020712 ()

  • Width: 1.5 Inch
  • Length: 3.5 Inch
  • Length: 1 Inch


  • Device sterilization/disinfection container, reusable

Avalign - 00190776021931

Accessory Box w/hardware
Avalign Technologies, Inc.
SCS21000
In Commercial Distribution

  • 00190776021931 ()

  • Width: 1.5 Inch
  • Length: 1 Inch
  • Length: 3.5 Inch


  • Device sterilization/disinfection container, reusable

Avalign - 00190776020125

Accessory Box with hardware
Avalign Technologies, Inc.
2000-100-036
In Commercial Distribution

  • 00190776020125 ()

  • Width: 1.5 Inch
  • Length: 3.5 Inch
  • Length: 1 Inch


  • Device sterilization/disinfection container, reusable
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