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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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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

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.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

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.® - 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™ - 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

AccuSensor - 00851491007012

AccuSensor Diagnostic ECG Tab Electrode
Lynn Medical Instrument Co.
930-100
In Commercial Distribution

  • 20851491007016 ()
  • 00851491007012 ()
  • 10851491007019 ()
930-100

  • Electrocardiographic electrode, single-use

Natural Extensions - 00366975000620

Mask, Earloop, Lavender
BENCO DENTAL SUPPLY CO.
3414-744
In Commercial Distribution

  • 20366975000624 ()
  • 10366975000627 ()
  • 00366975000620 ()


  • Surgical/medical face mask, single-use

AMT Bridle Pro® - 00842071131081

8 - 10 FR AMT Bridle Pro Nasal Tube Retaining System (Pediatric, Pouched)
APPLIED MEDICAL TECHNOLOGY, INC.
E4-420810P
In Commercial Distribution

  • 00842071131111 ()
  • 00842071131081 ()

  • Catheter Gauge: 8 French
  • Catheter Gauge: 10 French
E4-420810P, 4-420810P

  • Nasogastric tube holder, noninvasive

AMT Bridle Pro® - 00842071131074

5 - 6 FR AMT Bridle Pro Nasal Tube Retaining System (Pediatric, Pouched)
APPLIED MEDICAL TECHNOLOGY, INC.
E4-420506P
In Commercial Distribution

  • 00842071131104 ()
  • 00842071131074 ()

  • Catheter Gauge: 6 French
  • Catheter Gauge: 5 French
E4-420506P, 4-420506P

  • Nasogastric tube holder, noninvasive

AMT Bridle Pro® - 00842071131067

8F AMT Bridle Pro Nasal Tube Retaining System (Pediatric, Pouched)
APPLIED MEDICAL TECHNOLOGY, INC.
E4-4208P
In Commercial Distribution

  • 00842071131098 ()
  • 00842071131067 ()

  • Catheter Gauge: 8 French
E4-4208P, 4-4208P

  • Nasogastric tube holder, noninvasive

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

KWIK-STIK™ Plus - 10845357040685

KWIK-STIK™ Plus S. boydii (2) ATCC 8700™
MICROBIOLOGICS INC.
01209UX
Not in Commercial Distribution

  • 40845357040686 ()
  • 10845357040685 ()
01209UX

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ Plus - 10845357039146

KWIK-STIK™ Plus C. albicans ATCC 14053™
MICROBIOLOGICS INC.
0332UX
Not in Commercial Distribution

  • 40845357039147 ()
  • 10845357039146 ()
0332UX

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ Plus - 10845357039122

KWIK-STIK™ Plus M. luteus ATCC 4698™
MICROBIOLOGICS INC.
0242UX
Not in Commercial Distribution

  • 40845357039123 ()
  • 10845357039122 ()
0242UX

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ Plus - 10845357039115

KWIK-STIK™ Plus S. maltophilia ATCC 17666™
MICROBIOLOGICS INC.
0759UX
Not in Commercial Distribution

  • 40845357039116 ()
  • 10845357039115 ()
0759UX

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ Plus - 10845357039092

KWIK-STIK™ Plus B. agri ATCC 51663™
MICROBIOLOGICS INC.
0139UX
Not in Commercial Distribution

  • 40845357039093 ()
  • 10845357039092 ()
0139UX

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ Plus - 10845357039085

KWIK-STIK™ Plus E. casseliflavus ATCC 700327™
MICROBIOLOGICS INC.
0761UX
Not in Commercial Distribution

  • 40845357039086 ()
  • 10845357039085 ()
0761UX

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ Plus - 10845357039078

KWIK-STIK™ Plus B. cereus ATCC 11778™
MICROBIOLOGICS INC.
0256UX
Not in Commercial Distribution

  • 40845357039079 ()
  • 10845357039078 ()
0256UX

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ Plus - 10845357039061

KWIK-STIK™ Plus E. hormaechei ATCC 700323™
MICROBIOLOGICS INC.
0755UX
Not in Commercial Distribution

  • 40845357039062 ()
  • 10845357039061 ()
0755UX

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ Plus - 10845357039054

KWIK-STIK™ Plus S. saprophyticus ATCC BAA-750™
MICROBIOLOGICS INC.
0134UX
Not in Commercial Distribution

  • 40845357039055 ()
  • 10845357039054 ()
0134UX

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ Plus - 10845357038583

KWIK-STIK™ Plus S. aureus ATCC 29737™
MICROBIOLOGICS INC.
0906UX
Not in Commercial Distribution

  • 40845357038584 ()
  • 10845357038583 ()
0906UX

  • Multiple bacteria species culture isolate identification control IVD, kit

KWIK-STIK™ Plus - 10845357036268

KWIK-STIK™ Plus P. protegens (G) ATCC 17386™
MICROBIOLOGICS INC.
0524UX
Not in Commercial Distribution

  • 40845357036269 ()
  • 10845357036268 ()
0524UX

  • Multiple bacteria species culture isolate identification control IVD, kit
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