Burnshield

FDA UDI

Class U (US FDA UDI)

by Burnshield (pty) Ltd

Identity

Trade Name: Burnshield FDA UDI
Generic Name: Synthetic polymer burn dressing, gel-coated FDA UDI
Device Name: BURNSHIELD DRESS 20x45cm (8x18") FDA UDI
Model / Reference: 901001 FDA UDI
Description: BURNSHIELD DRESS 20x45cm (8x18") FDA UDI

Identifiers

Catalog Number: 901001 FDA UDI
Primary DI / UDI-DI: 06007645001410 FDA UDI
510(k) Number: K943728 FDA UDI
FDA Product Code: MGQ FDA UDI
GMDN Term: Synthetic polymer burn dressing, gel-coated FDA UDI

Classification

Device Class: U FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Weight — 270 Gram FDA UDI
Width — 450 Millimeter FDA UDI
Length — 200 Millimeter FDA UDI

Category: Synthetic polymer burn dressing, gel-coated

Burnshield by Burnshield (pty) Ltd — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Synthetic polymer burn dressing, gel-coated.

BurnFree — WATER-JEL TECHNOLOGIES, L.L.C. · Class I
First Responder — WATER-JEL TECHNOLOGIES, L.L.C. · Class I
First Responder — WATER-JEL TECHNOLOGIES, L.L.C. · Class I
Dukal — Dukal LLC · Class I
XeroBurn Sterile Burn Dressing Blanket 60"x 70" — Dynarex Corp. · Class I
BurnFree — WATER-JEL TECHNOLOGIES, L.L.C. · Class I
First Responder — WATER-JEL TECHNOLOGIES, L.L.C. · Class I
BurnFree — WATER-JEL TECHNOLOGIES, L.L.C. · Class I

Cleared under the same submission

K943728 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class U	Pending data

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Manufacturer

Manufacturer: Burnshield (pty) Ltd

Sources (1)

FDA UDI 5e5fab37-26b0-47cb-88ec-01763a498e97 38 fields · synced Jun 8, 2026