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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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Trinity with no TPS - 05055343880630

Trinity Non-occluded Titanium Plasma Spray Acetabular Shell Ø56mm Taper Size 4
CORIN LTD
320.04.356
In Commercial Distribution

  • 05055343880630 ()
320.04.356

  • Acetabular shell

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

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

Cobalt HV with Gentamicin - 00880304560796

No Description
Biomet Orthopedics, LLC
402283
In Commercial Distribution

  • 00880304560796 ()
402283

  • Orthopaedic cement, antimicrobial

Bracket with Tube Guide - 00709078013560

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

  • 10709078013574 ()
  • 00709078013560 ()


  • PEEP valve, single-use

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

DermaFilm Thin With border - 00714196391803

No Description
DERMARITE INDUSTRIES LLC
32670
In Commercial Distribution

  • 00714196391803 ()


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

DermaFilm thin with Border - 00714196391780

No Description
DERMARITE INDUSTRIES LLC
00229E
In Commercial Distribution

  • 00714196391780 ()


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

DermaFilm Thin with Border - 00714196391766

No Description
DERMARITE INDUSTRIES LLC
00306E
In Commercial Distribution

  • 00714196391766 ()


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

DermaFilm Thin with Border - 00714196391742

No Description
DERMARITE INDUSTRIES LLC
00259E
In Commercial Distribution

  • 00714196391742 ()


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

DermaFilm Thin With border - 00714196326706

No Description
DERMARITE INDUSTRIES LLC
32670
In Commercial Distribution

  • 00714196326706 ()
  • 01714196326705 ()


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

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

DermaFilm Thin with Border - 00714196306661

No Description
DERMARITE INDUSTRIES LLC
00306E
In Commercial Distribution

  • 00714196306661 ()
  • 00171419630666 ()


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

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

Assistant with StableSoft 2S - 00699753450530

No Description
Terumo Cardiovascular Systems Corporation
45053
In Commercial Distribution

  • 50699753450535 ()
  • 00699753450530 ()


  • Cardiopulmonary bypass system blood tubing set

Assistant with StableSoft 2L - 00699753450523

No Description
Terumo Cardiovascular Systems Corporation
45052
In Commercial Distribution

  • 50699753450528 ()
  • 00699753450523 ()


  • Cardiopulmonary bypass system blood tubing set

Assistant with StableSoft 3S - 00699753450516

No Description
Terumo Cardiovascular Systems Corporation
45051
In Commercial Distribution

  • 50699753450511 ()
  • 00699753450516 ()


  • Cardiopulmonary bypass system blood tubing set

Assistant with StableSoft 3L - 00699753450509

No Description
Terumo Cardiovascular Systems Corporation
45050
In Commercial Distribution

  • 50699753450504 ()
  • 00699753450509 ()


  • Cardiopulmonary bypass system blood tubing set

CURVED RASP WITH ELEVATOR - 00880304405035

No Description
Biomet Orthopedics, LLC
903719
In Commercial Distribution

  • 00880304405035 ()
903719

  • Bone file/rasp, manual, reusable

CANNULATED REAMER WITH STOP - 00880304384514

No Description
Biomet Orthopedics, LLC
471782
In Commercial Distribution

  • 00880304384514 ()
471782

  • Bone-resection orthopaedic reamer, reusable

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
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