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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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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

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

iReveal with PowerLook AMP - 00858012005656

PowerLook Density Assessment software application intended for use with digital mammography systems. PowerLook Density Assessment calculates breast density as a ratio of fibroglandular tissue and total breast area estimates. PowerLook Density Assessment provides these numerical values for each breast as well as a density category to aid radiologists in the assessment of breast tissue composition. PowerLook Density Assessment produces adjunctive information. It is not an interpretive or diagnostic aid.
Icad, Inc.
V2.1
In Commercial Distribution

  • 00858012005656 ()
DSC012

  • Basic diagnostic x-ray system application software

Tip with Indexable Stop - 08057639710574

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

  • 08057639710574 ()


  • Bone tack inserter, basic

Nitrile PF with Aloe - 00649531320777

Nitrile Exam Glove with Aloe, Green, X-Large
Dash Medical Gloves, Inc.
NA100XL
In Commercial Distribution

  • 00649531420774 ()
  • 00649531320777 ()
  • 00649531320074 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Nitrile PF with Aloe - 00649531320760

Nitrile Exam Glove with Aloe, Green, Large
Dash Medical Gloves, Inc.
NA100L
In Commercial Distribution

  • 00649531420767 ()
  • 00649531320760 ()
  • 00649531320067 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Nitrile PF with Aloe - 00649531320746

Nitrile Exam Glove with Aloe, Green, Medium
Dash Medical Gloves, Inc.
NA100M
In Commercial Distribution

  • 00649531420743 ()
  • 00649531320746 ()
  • 00649531320043 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

Nitrile PF with Aloe - 00649531320722

Nitrile Exam Glove with Aloe, Green, Small
Dash Medical Gloves, Inc.
NA100S
In Commercial Distribution

  • 00649531420729 ()
  • 00649531320722 ()
  • 00649531320029 ()


  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial

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

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

Otoport - Screener with ABR - 05060396171062

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

  • 05060396171062 ()


  • Evoked-potential audiometer

T-Handle with Quick Coupling - 06902139111982

No Description
Double Medical Technology Inc.
111190600
In Commercial Distribution

  • 06902139111982 ()
111190600

  • Surgical drill guide, reusable

Non-Rebreather Mask with GSL - 00709078004469

Non-Rebreather Mask with GSL, filter and adapter
WESTMED, INC.
0364
Not in Commercial Distribution

  • 00709078004469 ()


  • Heat/moisture exchanger/microbial medical gas filter
  • Non-rebreathing oxygen face mask

Reduction Forceps with Point - 06902139110985

No Description
Double Medical Technology Inc.
110071900
In Commercial Distribution

  • 06902139110985 ()
110071900

  • Surgical implant handling forceps

Reduction Forceps with Points - 06902139110664

No Description
Double Medical Technology Inc.
110041900
In Commercial Distribution

  • 06902139110664 ()
110041900

  • Surgical implant handling forceps

T-Handle with Quick Coupling - 06902139110596

No Description
Double Medical Technology Inc.
110041400
In Commercial Distribution

  • 06902139110596 ()
110041400

  • Surgical drill guide, reusable

Biteblock with elastic necktape - 04250105605525

#6 ; suitable for Laryngeal Tubes: LTS-D #3, #4, #5 / Laryngeal Masks: #3, #4, #5
VBM Medizintechnik GmbH
40-66-060-1
In Commercial Distribution

  • 14250105605522 ()
  • 04250105605525 ()


  • Oropharyngeal airway, single-use

Biteblock with elastic necktape - 04250105604955

#5 ; suitable for Tracheal Tubes: 8.5 - 11.0 mm I.D. / Laryngeal Tubes: LTS-D #2, #2.5
VBM Medizintechnik GmbH
40-66-050-1
In Commercial Distribution

  • 14250105604952 ()
  • 04250105604955 ()


  • Oropharyngeal airway, single-use

Biteblock with elastic necktape - 04250105604948

#4 ; suitable for Tracheal Tubes: 6.5 - 8.0 mm I.D. / Laryngeal Masks: #2, #2.5
VBM Medizintechnik GmbH
40-66-040-1
In Commercial Distribution

  • 14250105604945 ()
  • 04250105604948 ()


  • Oropharyngeal airway, single-use

AuDX Device with touchscreen - 04260223143281

AuDX branded Sentiero
PATH medical GmbH
100098-AU
In Commercial Distribution

  • 04260223143281 ()


  • Evoked-potential audiometer
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