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Device Explorer · FDA GUDID · GMDN 47406

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

A pad made of open-cell foam material designed to be placed into a wound during a vacuum-assisted wound closure procedure, commonly known as negative pressure wound therapy (NPWT); it does not include an antimicrobial agent(s). It is typically used to treat ha

US‑registered devices228in commercial distribution
Companies14labelers on GUDID
Single‑use100%of device records
Sterile85%labelled sterile
Prescription91%Rx‑only share
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Share of device records

Kci Usa, Inc.6830%
Genadyne Biotechnologies Inc.5926%
Carilex Medical, Inc.3515%
Deroyal Industries, Inc.2611%
Alleva Medical Limited94%
Pensar Medical, Llc63%
Clear Choice Therapeutics, Inc.63%
Stryker Corporation52%

Top labelers

CompanyDevicesShare
Kci Usa, Inc.6830%
Genadyne Biotechnologies Inc.5926%
Carilex Medical, Inc.3515%
Deroyal Industries, Inc.2611%
Alleva Medical Limited94%
Pensar Medical, Llc63%
Clear Choice Therapeutics, Inc.63%
Stryker Corporation52%
Lc Medical Concepts52%
Dynarex Corporation42%
Solventum Us Llc21%
Mölnlycke Health Care Ab10%

Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Avance® SoloExtriCAREExtricareNAV.A.C.® GRANUFOAM™V.A.C.® SIMPLACE™V.A.C. ® GRANUFOAM™NPSealHydrophilic Foam Dressing, MediumHydrophilic Foam Dressing, SmallTheia Negative Pressure Wound Therapy Foam Dress3M™ V.A.C.® Granufoam™DERMATAC™ DRAPE and V.A.C.® GRANUFOAM™ DRESSING3M™ Prevena Restor™ Adaptiform™3M™ Veraflo™ Cleanse Choice Complete™V.A.C. DERMATAC™ DRAPE and V.A.C. GRANUFOAM™ DRE

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
OMPNegative Pressure Wound Therapy Powered Suction Pump153
OMPnegative pressure wound therapy Powered suction pump57
NACDressing, wound, hydrophilic14
KDDKit, surgical instrument, disposable12
NADDressing, Wound, Occlusive10
OKONegative Pressure Wound Therapy Non-Powered Suction Apparatu5

GMDN & GCC registration

  • GMDN code 47406 · non‑implantable
  • Single‑use 100% · sterile 85% · Rx‑only 91% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Centimeter) · 10Width (Centimeter) · 10Depth (Centimeter) · 10

Use these as the dimensions to specify in a tender line.

How many negative-pressure wound therapy system foam dressing, non-antimicrobial products are registered in the US?

228 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Negative-pressure wound therapy system foam dressing, non-antimicrobial", from 14 companies. The largest labeler is Kci Usa, Inc. with 30% of records.

Which FDA product codes apply?

OMP (Negative Pressure Wound Therapy Powered Suction Pump), OMP (negative pressure wound therapy Powered suction pump), NAC (Dressing, wound, hydrophilic), KDD (Kit, surgical instrument, disposable)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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