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Device Explorer · FDA GUDID · GMDN 47693

Synthetic polymer burn dressing, gel-coated

A sterile covering designed to treat small to large patient burns. It is made from synthetic polymer material impregnated with wound gel (e.g., hydrogel) and is applied over the burn to protect against infection, minimize trauma and skin damage, moisten and co

US‑registered devices62in commercial distribution
Companies8labelers on GUDID
Single‑use100%of device records
Sterile94%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Water-Jel Technologies, L.L.C.2540%
Burnshield (Pty) Ltd1524%
Dynarex Corporation1118%
Emsrun Group35%
Dukal Llc35%
Prostat First Aid, Llc23%
Redicare Llc23%
Acme United Corporation12%

Top labelers

CompanyDevicesShare
Water-Jel Technologies, L.L.C.2540%
Burnshield (Pty) Ltd1524%
Dynarex Corporation1118%
Emsrun Group35%
Dukal Llc35%
Prostat First Aid, Llc23%
Redicare Llc23%
Acme United Corporation12%

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

Brand names on the register (sample)

Rhino RescuePrepEM WildBURNSHIELDBurnshield"DynaSafety XeroBurn Sterile Burn Dressing, 8"" "DynaSafety XeroBurn Sterile Burn Dressing, 16"""DynaSafety XeroBurn Sterile Burn Dressing, 12"""DynaSafety XeroBurn Sterile Burn Dressing, 8"" "DynaSafety XeroBurn Sterile Burn Dressing, 2"" XeroBurn Burn Dressing Face Mask- Sterile"XeroBurn Sterile Burn Dressing Blanket 70"" x 9"XeroBurn Sterile Burn Dressing Blanket 60""x 70XeroBurn Sterile Burn Dressing Blanket" XeroBurn Sterile Burn Dressings, 4"" x 4"""ARAMARKFRONT LINE

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

FDA product codes

CodeNameDevices
NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic43
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic15
NAEDressing, wound, hydrogel without drug and/or biologic4
NADDressing, Wound, Occlusive1

GMDN & GCC registration

  • GMDN code 47693 · non‑implantable
  • Single‑use 100% · sterile 94% · Rx‑only 0% · OTC 74%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Millimeter) · 10Width (Millimeter) · 10Weight (Gram) · 9Width (Centimeter) · 2Length (Centimeter) · 2

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

How many synthetic polymer burn dressing, gel-coated products are registered in the US?

62 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Synthetic polymer burn dressing, gel-coated", from 8 companies. The largest labeler is Water-Jel Technologies, L.L.C. with 40% of records.

Which FDA product codes apply?

NAE (Dressing, Wound, Hydrogel Without Drug And/Or Biologic), MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic), NAE (Dressing, wound, hydrogel without drug and/or biologic), NAD (Dressing, Wound, Occlusive)

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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