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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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DermaFilm Thin with Border - 00714196259448

No Description
DERMARITE INDUSTRIES LLC
00259E
In Commercial Distribution

  • 00714196259448 ()
  • 01714196259447 ()


  • Exudate-absorbent dressing, non-gel, non-antimicrobial

DermaFilm thin with Border - 00714196229229

No Description
DERMARITE INDUSTRIES LLC
00229E
In Commercial Distribution

  • 00714196229229 ()
  • 01714196229228 ()


  • Exudate-absorbent dressing, non-gel, non-antimicrobial

Perfusion Clamp with Adaptor - 13700911900942

The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
INSTITUT GEORGES LOPEZ
PC1025A
In Commercial Distribution

  • 23700911900949 ()
  • 13700911900942 ()
  • 53700911900940 ()
  • 33700911900946 ()


  • Kidney donor-organ preservation/transport perfusion set

Perfusion Clamp with Adaptor - 13700911900935

The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
INSTITUT GEORGES LOPEZ
PC715A
In Commercial Distribution

  • 23700911900932 ()
  • 13700911900935 ()
  • 53700911900933 ()
  • 33700911900939 ()


  • Kidney donor-organ preservation/transport perfusion set

Perfusion Clamp with Adaptor - 13700911900928

The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
INSTITUT GEORGES LOPEZ
PC1020A
In Commercial Distribution

  • 23700911900925 ()
  • 13700911900928 ()
  • 53700911900926 ()
  • 33700911900922 ()


  • Kidney donor-organ preservation/transport perfusion set

Bracket with Tube Guide - 00709078013560

Bracket with Tube Guide
WESTMED, INC.
WP-7704
In Commercial Distribution

  • 10709078013574 ()
  • 00709078013560 ()


  • PEEP valve, single-use

SuperPole FRS with SuperBar - 00689281035866

The SuperPole F.R.S. (floor receptacle system) with SuperBar is a high quality, commercial grade pivoting and locking horizontal bar that connects to the SuperPole F.R.S. (a support pole that interfaces with and is supported by a receptacle that is permanently embedded into a structural concrete floor). The horizontal bar can be lifted, pivoted, and lowered to the next locking position around the F.R.S. pole. The SuperBar is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The SuperBar is installed onto the SuperPole F.R.S. by securing a castellated collar to the pole with 3 cone point set screws. The set screws pierce into the pole and lock the collar in place, and the spring ring is used to prevent the set screws from back-threading. The castellated collar has 8 grooves strong enough for the SuperBar to support the user. When the SuperPole F.R.S. is removed from the concrete receptacle, the receptacle must be covered with a floor flush cap to provide a water-tight seal. The maximum user weight for this product is 450lbs / 205kgs. Product is not intended to support full body weight.
Healthcraft Products Inc.
FRS-SPB
In Commercial Distribution

  • 00689281035866 ()
03596

  • Hand rail

Cobalt MV with Gentamicin - 00880304476783

No Description
Biomet Orthopedics, LLC
402439
In Commercial Distribution

  • 00880304476783 ()
402439

  • Orthopaedic cement, antimicrobial

TOGGLELOC XL WITH ZIPLOOP - 00880304567641

No Description
Biomet Orthopedics, LLC
110005089
In Commercial Distribution

  • 00880304567641 ()
110005089

  • Ligament bone anchor

ToggleLoc With Ziploop Inline - 00880304567634

No Description
Biomet Orthopedics, LLC
110005087
In Commercial Distribution

  • 00880304567634 ()
110005087

  • Tendon/ligament bone anchor, non-bioabsorbable

AP70(with long antenna) - 06936415973537

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-071010-00
In Commercial Distribution

  • 06936415973537 ()


  • General-purpose multi-parameter bedside monitor

Cobalt HV with Gentamicin - 00880304560796

No Description
Biomet Orthopedics, LLC
402283
In Commercial Distribution

  • 00880304560796 ()
402283

  • Orthopaedic cement, antimicrobial

Fixation Forceps with teeth - 00883475953718

No Description
CHARMANT INC.
37-0075
In Commercial Distribution

  • 00883475953718 ()


  • Ophthalmic surgical device handling forceps, reusable

Caliper with Handle(G) - 00883475952988

No Description
CHARMANT INC.
37-0064
In Commercial Distribution

  • 00883475952988 ()


  • Corneal marker, reusable

Speculum with Locking Screw - 00883475952957

No Description
CHARMANT INC.
37-0063
In Commercial Distribution

  • 00883475952957 ()


  • Eyelid speculum, reusable

Fixation Forceps with teeth - 00883475952285

No Description
CHARMANT INC.
37-0060
In Commercial Distribution

  • 00883475952285 ()


  • Ophthalmic surgical device handling forceps, reusable

Wire Speculum with Blade - 00883475651386

No Description
CHARMANT INC.
37-0010
In Commercial Distribution

  • 00883475651386 ()


  • Eyelid speculum, reusable

Tri-Seal mouthseal with mouthpiece - 00850644007589

blue vinyl, 22mm OD, 50/bx
Vacumed
1007-MP
In Commercial Distribution

  • 00850644007589 ()
  • 08506440075896 ()
1007-MP

  • Breathing mouthpiece, single-use

ExuCare Small with foot - 00850051939473

A wound cover that wraps around the leg and foot which is intended to be used as an initial, short-term treatment after injury that consists of an absorbent pad (e.g., gauze, cotton wool, lint, cellulose) The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding. This is a single-use device.
SUN SCIENTIFIC, INC.
EC6150
In Commercial Distribution

  • 00850051939473 ()
ECWF100

  • First aid absorbent pad/bandage

ExuCare Large with foot - 00850051939381

A wound cover that wraps around the leg and foot which is intended to be used as an initial, short-term treatment after injury that consists of an absorbent pad (e.g., gauze, cotton wool, lint, cellulose) The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding. This is a single-use device.
SUN SCIENTIFIC, INC.
EC6350
In Commercial Distribution

  • 00850051939381 ()
ECWF300

  • First aid absorbent pad/bandage

Inspirachamber with InspiraMask (Large) - 00852367007013

InspiraChamber Anti-Static Valved Holding Chamber with InspiraMask- Hospital Unit
INSPIRX, INC
IC-IML-0
In Commercial Distribution

  • 00852367007013 ()
  • 10852367007010 ()


  • Medicine chamber spacer, reusable

FlexGuide ULTRA with Tray - 00852306007302

FlexGuide ULTRA set with Fleguide Handpiece and Tray
OMNIGUIDE, INC.
FLEX-ULTRA SET
In Commercial Distribution

  • 00852306007302 ()
FLEX-ULTRA SET

  • Urogenital surgical laser system beam guide, reusable

Tip with Indexable Stop - 08057639710574

Tip with Indexable Stop for MCBio Tacks
MC BIO SRL
9570566
In Commercial Distribution

  • 08057639710574 ()


  • Bone tack inserter, basic

Otoport - Screener with ABR - 05060396171062

No Description
OTODYNAMICS LIMITED
OS-ST+ABR
In Commercial Distribution

  • 05060396171062 ()


  • Evoked-potential audiometer

Inspirachamber with Inspiramask (Large) - 00327437043012

Inspirachamber Anti-static Valved Holding Chamber with InspiraMask (Large) (Retail Unit)
LUPIN PHARMACEUTICALS, INC.
IPX1043
In Commercial Distribution

  • 30327437043013 ()
  • 00327437043012 ()


  • Medicine chamber spacer, reusable

Hook, with Ball 35cm - 04057034120774

Hook, with Ball 35cm ValveGate™
Geister Medizintechnik GmbH
34-7486
In Commercial Distribution

  • 04057034120774 ()
34-7486

  • Hand-held surgical retractor, reusable

Flexarm, OPCAB with carrier - 04057034095393

Flexarm, OPCAB with carrier CardioFrame™
Geister Medizintechnik GmbH
29-1486
In Commercial Distribution

  • 04057034095393 ()
29-1486

  • Self-retaining surgical retractor, reusable

System Drape with Pocket - 00841912100675

No Description
PROTEK MEDICAL PRODUCTS, INC.
1217
In Commercial Distribution

  • 10841912100672 ()
  • 00841912100675 ()
1217

  • Medical equipment/instrument drape, single-use

Mattress with flat surface - 04056869008790

No Description
Siemens Healthcare GmbH
08096856
In Commercial Distribution

  • 04056869008790 ()


  • Full-body CT system

Satellite with Satellite Cord - 00195062031038

Satellite with Satellite Cord
Kerr Corporation
973-0303
In Commercial Distribution

  • 00195062031038 ()


  • Dental pulp analysis system

Ceph attachment with sensor - 00841709102752

Ceph attachment with sensor
MIDMARK CORPORATION
C6000
In Commercial Distribution

  • 00841709102752 ()
C6000

  • Stationary cephalometric x-ray system, digital

Syvek Brace with Straps - 00389142000032

Syvek Brace with Straps
Marine Polymer Technologies, Inc.
420-05
In Commercial Distribution

  • 10389142000039 ()
  • 00389142000032 ()


  • Wrist immobilizer, single-use

Suction Unit with Base - 00616784082110

No Description
Dynarex Corporation
10821
In Commercial Distribution

  • 00616784082110 ()


  • Surgical suction system collection container, single-use

Trapeze Bar with Stand - 00616784071015

No Description
Dynarex Corporation
10710
In Commercial Distribution

  • 00616784071015 ()


  • Parallel bar exerciser, non-powered

Foot Stool with Handle - 00616784055213

Foot Stool with Handle, Weight Capacity 300 lbs.
Dynarex Corporation
10552
In Commercial Distribution

  • 00616784055213 ()


  • Footstool

Overbed Table with U-Base - 00616784045511

Overbed Table with U-Base, Light Oak and White, 32"x16" Adjustable Height 28" to 43"
Dynarex Corporation
10455
In Commercial Distribution

  • 00616784045511 ()


  • Overbed table

Overbed Table with U-Base - 00616784045412

Overbed Table with U-Base, Mahogany and White, 32"x16", Adjustable Height 28" to 43"
Dynarex Corporation
10454
In Commercial Distribution

  • 00616784045412 ()


  • Overbed table

Overbed Table with U-Base - 00616784045313

Overbed Table with U-Base, Amber Cherry and White, 32"x16", Adjustable Height 28" to 43"
Dynarex Corporation
10453
In Commercial Distribution

  • 00616784045313 ()


  • Overbed table

Circulatory Circuit with RF32 - 00607567209978

BEQ-HMOD 70000-USA Adult Quadrox iD, BEQ-RF32 RotaFlow, Gas Filter
DATASCOPE CORP.
BEQ-TOP 53600
In Commercial Distribution

  • 00607567209978 ()
709000218

  • Cardiopulmonary bypass system blood tubing set

Adult ECC with RF32 - 00607567207141

Softshell venous reservoir 1900 BEQ-RF32 RotaFlow
DATASCOPE CORP.
BEQ-T 21308
Not in Commercial Distribution

  • 00607567207141 ()
701068376

  • Cardiopulmonary bypass system blood tubing set
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