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Device Explorer · FDA GUDID · GMDN 58302

Antimicrobial synthetic polymer semi-permeable film dressing, adhesive

A sterile, transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue to provide protection (e.g., from dirt, water) and/or promote healing, and that contains an antimicrobial agent.

US‑registered devices87in commercial distribution
Companies8labelers on GUDID
Single‑use100%of device records
Sterile77%labelled sterile
Prescription70%Rx‑only share
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Share of device records

Deroyal Industries, Inc.2124%
3M Company1618%
Aspen Surgical Products, Inc.1517%
Covalon Technologies Ltd1113%
Medsource International Llc89%
Entrotech Life Sciences, Llc89%
Solventum Us Llc67%
Cardinal Health 110, Inc.22%

Top labelers

CompanyDevicesShare
Deroyal Industries, Inc.2124%
3M Company1618%
Aspen Surgical Products, Inc.1517%
Covalon Technologies Ltd1113%
Medsource International Llc89%
Entrotech Life Sciences, Llc89%
Solventum Us Llc67%
Cardinal Health 110, Inc.22%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Aspen® Transparent Border DressingTransparent DressingCardinal Thumb Transparent DressingIV Clear 10x12cm notch dressing with securement IV Clear 6x7 with notch and tape stripsIV Clear 10x12cm cover dressingSurgiClear 6x30SurgiClear 6x25SurgiClear 6x20SurgiClear 10x12SurgiClear 4x13SurgiClear 4x7IV Clear 6x7 cover dressingIV Clear 10x12cm with notch and tape stripsMedSource Transparent DressingMedSource I.V. Guard

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

FDA product codes

CodeNameDevices
FRODressing, wound, drug43
FRODressing, Wound, Drug25
NADDressing, wound, occlusive15
NACDressing, Wound, Hydrophilic8
NACDressing, wound, hydrophilic2
PEZCentral venous catheter dressing change kit1

GMDN & GCC registration

  • GMDN code 58302 · non‑implantable
  • Single‑use 100% · sterile 77% · Rx‑only 70% · OTC 2%
  • 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) · 14Width (Centimeter) · 14Width (Inch) · 2Length (Inch) · 2

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

How many antimicrobial synthetic polymer semi-permeable film dressing, adhesive products are registered in the US?

87 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Antimicrobial synthetic polymer semi-permeable film dressing, adhesive", from 8 companies. The largest labeler is Deroyal Industries, Inc. with 24% of records.

Which FDA product codes apply?

FRO (Dressing, wound, drug), FRO (Dressing, Wound, Drug), NAD (Dressing, wound, occlusive), NAC (Dressing, Wound, Hydrophilic)

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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