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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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CardioWrap® - 08964050362025

Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L-lactide). Indicated for use as a pericardium replacement device in patients that may require re-operation within six months.
MAST BIOSURGERY USA INC.
100 x 130 x 0.02mm
Not in Commercial Distribution

  • 18964050362022 ()
  • 08964050362025 ()

  • Length: 130 Millimeter
  • Width: 100 Millimeter
  • Thickness: 0.02 Millimeter
36202-01

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

PREVENA PLUS™ - 00849554005310

Prevena Plus 150 ml Canister
KCI USA, INC.
Prevena Plus 150 ml Canister
In Commercial Distribution

  • 00849554005310 ()
  • 00849554005327 ()


  • Negative-pressure wound therapy system, electric, single-use

PREVENA PLUS™ CUSTOMIZABLE™ - 00849554005303

Prevena Plus Customizable Dressing with Sensatrac Technology
KCI USA, INC.
Prevena Plus Customizable Dressing
In Commercial Distribution

  • 00849554005303 ()
  • 00849554005334 ()


  • Negative-pressure wound therapy system, electric, single-use

V.A.C. VERAFLO™ - 00849554004733

Vac Veraflo Cleanse Choice Dressing- Medium
KCI USA, INC.
ULTVCC05MD
In Commercial Distribution

  • 00849554004733 ()
  • 00849554004726 ()


  • Irrigation negative-pressure wound therapy dressing

V.A.C.VIA™ GRANUFOAM™ - 00849554003774

Vac Via Dressing Small
KCI USA, INC.
VIAGFS05
In Commercial Distribution

  • 00849554003774 ()
  • 00849554002319 ()


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial

V.A.C.VIA™ GRANUFOAM™ - 00849554003767

VAC VIA Dressing Medium Featuring a Granufoam Spiral Dressing
KCI USA, INC.
VIAGFM05
In Commercial Distribution

  • 00849554003767 ()
  • 00849554002296 ()


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial

V.A.C.VIA™ - 00849554003750

VAC VIA 250ml Canister
KCI USA, INC.
VIACAN05
In Commercial Distribution

  • 00849554003750 ()
  • 00849554002289 ()


  • Negative-pressure wound therapy system canister

V.A.C.® - 00849554002562

Vac Abdominal Dressing Featuring Sensatrac Technology
KCI USA, INC.
M8275080/5
Not in Commercial Distribution

  • 00849554002562 ()
  • 00878237001424 ()


  • Negative-pressure wound therapy open-abdomen dressing

V.A.C.® GRANUFOAM™ - 00849554002555

Vac Granufoam Dressing X-Large Featuring Sensatrac Technology
KCI USA, INC.
M8275065/5
In Commercial Distribution

  • 00849554002555 ()
  • 00849554000841 ()


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial

V.A.C.® GRANUFOAM™ - 00849554002548

Vac Granufoam Hand Dressing Featuring Sensatrac Technology
KCI USA, INC.
M8275064/5
In Commercial Distribution

  • 00849554002548 ()
  • 00849554000834 ()


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial

INFOV.A.C.™ - 00849554002067

1000 ml Canister (with Gel) for Infovac and VAC Ulta Therapy Systems
KCI USA, INC.
M8275093/5
In Commercial Distribution

  • 00849554002067 ()
  • 00849554002050 ()


  • Negative-pressure wound therapy system canister

V.A.C.® GRANUFOAM™ - 00849554001961

Vac Granufoam Bridge XG Dressing
KCI USA, INC.
M8275044/5
In Commercial Distribution

  • 00849554001961 ()
  • 00849554001022 ()


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial

V.A.C. VERAFLO™ - 00849554001909

VAC Veraflo
KCI USA, INC.
ULTVFL05LG
In Commercial Distribution

  • 00849554001909 ()
  • 00849554001893 ()


  • Irrigation negative-pressure wound therapy dressing

V.A.C. VERAT.R.A.C. DUO™ - 00849554001374

Vac Veratrac Duo Tube Set
KCI USA, INC.
ULTDUO0500
In Commercial Distribution

  • 00849554001374 ()
  • 00849554000162 ()


  • Negative-pressure wound therapy tubing set

V.A.C.® SIMPLACE™ - 00849554001367

VAC Simplace Ex Dressing Small
KCI USA, INC.
M8275046/5
In Commercial Distribution

  • 00849554001367 ()
  • 00849554001046 ()


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial

V.A.C.® SIMPLACE™ - 00849554001350

VAC Simplace Ex Dressing Medium
KCI USA, INC.
M8275045/5
In Commercial Distribution

  • 00849554001350 ()
  • 00849554001039 ()


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial

V.A.C.® - 00849554001336

KCI NPWT Gauze Dressing Large Featuring Sensatrac Technology
KCI USA, INC.
413716
In Commercial Distribution

  • 00849554001336 ()
  • 00849554001251 ()


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial

V.A.C. VERAT.R.A.C. DUO™ - 00849554001329

Vac Veraflo Cleanse Dressing System
KCI USA, INC.
ULTCL05MD
In Commercial Distribution

  • 00849554001329 ()
  • 00849554000179 ()


  • Irrigation negative-pressure wound therapy dressing

V.A.C. VERAFLO™ - 00849554001305

VAC Veraflo Dressing System Medium
KCI USA, INC.
ULTVFL05MD
In Commercial Distribution

  • 00849554001305 ()
  • 00849554000155 ()


  • Irrigation negative-pressure wound therapy dressing

V.A.C. VERAFLO™ - 00849554001299

Vac Veraflo Dressing System Small
KCI USA, INC.
ULTVFL05SM
In Commercial Distribution

  • 00849554001299 ()
  • 00849554000148 ()


  • Irrigation negative-pressure wound therapy dressing

ABTHERA™ SENSAT.R.A.C.™ - 00849554001282

Abthera Open Abdomen Dressing with Sensatrac pad
KCI USA, INC.
M8275026/5
In Commercial Distribution

  • 00849554001282 ()
  • 00849554000216 ()


  • Negative-pressure wound therapy open-abdomen dressing

ABTHERA™ - 00849554001275

Abthera Tubing Set
KCI USA, INC.
370642
In Commercial Distribution

  • 00849554001275 ()
  • 00849554000230 ()


  • Negative-pressure wound therapy tubing set

ABTHERA™ - 00849554001268

Abthera Open Abdomen Dressing
KCI USA, INC.
370605
In Commercial Distribution

  • 00849554001268 ()
  • 00849554000223 ()


  • Negative-pressure wound therapy open-abdomen dressing

CELLUTOME™ - 00849554001220

Cellutome Epidermal Harvesting System Harvester (5.0cm)
KCI USA, INC.
CT-H50
In Commercial Distribution

  • 00849554001220 ()
  • 00849554001206 ()


  • Dermatome handpiece, electrically-powered

CELLUTOME™ - 00849554001213

Cellutome Epidermal Harvesting System Harvester (2.5cm)
KCI USA, INC.
CT-H25
In Commercial Distribution

  • 00849554001213 ()
  • 00849554001190 ()


  • Dermatome handpiece, electrically-powered

PREVENA™ CUSTOMIZABLE™ - 00849554000087

Prevena Customizable Dressing
KCI USA, INC.
Prevena Customizable Dressing
In Commercial Distribution

  • 00849554000087 ()
  • 00849554000070 ()


  • Negative-pressure wound therapy system, electric, single-use

PREVENA™ - 00849554000032

Prevena 45 ml canister
KCI USA, INC.
Prevena 45 ml canister
In Commercial Distribution

  • 00849554000032 ()
  • 00849554000025 ()


  • Negative-pressure wound therapy system, electric, single-use

PREVENA™ PEEL & PLACE™ - 00849554000018

Prevena Peel & Place Dressing- 20 cm Prevena Patch Strips
KCI USA, INC.
Prevena Peel & Place Dressing- 20 cm
In Commercial Distribution

  • 00849554000018 ()
  • 00849554000131 ()


  • Negative-pressure wound therapy system, electric, single-use

ABTHERA ADVANCE™ - 00849554006966

ABTHERA ADVANCE™ OPEN ABDOMEN DRESSING
KCI USA, INC.
ABT1055
In Commercial Distribution

  • 00849554006966 ()
  • 00849554006942 ()


  • Negative-pressure wound therapy open-abdomen dressing

V.A.C.ULTA™ - 00849554006775

Solution Container Hanger Arm Extension
KCI USA, INC.
ULTEXT0500
Not in Commercial Distribution

  • 00849554006775 ()
  • 00849554006782 ()


  • Frame/rail/pole device holder

PREVENA™ PEEL & PLACE™ - 00849554006416

Prevena Peel & Place Dressing- 35 cm
KCI USA, INC.
Prevena Peel & Place Dressing- 35 cm
In Commercial Distribution

  • 00849554006416 ()
  • 00849554006379 ()


  • Negative-pressure wound therapy system, electric, single-use

V.A.C. VERAFLO Cleanse Choice™ - 00849554006256

V.A.C. VERAFLO Cleanse Choice™ DRESSING LARGE
KCI USA, INC.
ULTVCC05LG
In Commercial Distribution

  • 00849554006263 ()
  • 00849554006256 ()


  • Irrigation negative-pressure wound therapy dressing

V.A.C. ® - 00849554005020

VAC Drape XL
KCI USA, INC.
M6275097/5
Not in Commercial Distribution

  • 00849554005020 ()
  • 00849554005013 ()


  • Negative-pressure wound therapy tubing set

V.A.C.VIA™ - 00849554003156

VAC Via System Starter Kit
KCI USA, INC.
VIAKIT07S05/US
In Commercial Distribution

  • 00849554003156 ()
  • 00849554002449 ()


  • Negative-pressure wound therapy system, electric, single-use

V.A.C.® GRANUFOAM™ - 00849554002579

SENSATRAC, HEEL DRESSING/POUCH
KCI USA, INC.
320913
Not in Commercial Distribution

  • 00849554002579 ()
  • 00849554000858 ()


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial

Orabloc - needle stick safety system - 08051040583000

The Needlestick Safety system is designed for safely recapping needles. The device consists of a disk, filled with 100 micro rubber caps, suitable for recapping needles after utilisation, for a safe disposal.
PIERREL SPA
20200707
In Commercial Distribution

  • 08051040583000 ()

  • 100 capsules that fit a range of needle sizes
20200707

  • Needle recapping device, single-use

Henry Schein - H65857003841

Spirette Mouthpiece
HENRY SCHEIN, INC.
5700384
In Commercial Distribution

  • H65857003841 ()
  • H65857003849 ()
5700384

  • Breathing mouthpiece, single-use

Henry Schein - H65857003831

Spirette Mouthpiece
HENRY SCHEIN, INC.
5700383
In Commercial Distribution

  • H65857003831 ()
  • H65857003839 ()
5700383

  • Breathing mouthpiece, single-use

SURGUARD2 - 34806017512942

SURGUARD2 Safety Hypodermic Needle
TERUMO (PHILIPPINES) CORPORATION
10180094
In Commercial Distribution

  • 54806017512946 ()
  • 34806017512942 ()
  • 14806017512948 ()

  • Needle Gauge: 27 Gauge
  • Length: 0.5 Inch


  • Hypodermic needle, single-use

WOODPECKER - 06944843610047

Ultrasonic dental scaling/debridement system
Guilin Woodpecker Medical Instrument Co., Ltd.
PT 5
In Commercial Distribution

  • 06944843610047 ()


  • Ultrasonic dental scaling/debridement system
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