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Burnshield

FDA UDI

Class U (US FDA UDI)

by Burnshield (pty) Ltd

Identity

Trade Name
Burnshield FDA UDI
Generic Name
Burn gel FDA UDI
Device Name
BURNSHIELD CONTOUR KIT SINGLE FDA UDI
Model / Reference
881008 FDA UDI
Description
BURNSHIELD CONTOUR KIT SINGLE FDA UDI

Identifiers

Catalog Number
881008 FDA UDI
Primary DI / UDI-DI
06007645007665 FDA UDI
510(k) Number
K943728 FDA UDI
FDA Product Code
MGQ FDA UDI
GMDN Term
Burn gel 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Burn gelCotton burn dressing, non-antimicrobial

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

Similar devices

Also classified as Cotton burn dressing, non-antimicrobial.

Cleared under the same submission

K943728 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Burnshield (pty) Ltd

Sources (1)

  • FDA UDI 42f77eea-6446-461f-8e4a-8a0d00dbb530 37 fields · synced Jun 8, 2026