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Burnshield

FDA UDI

Class U (US FDA UDI)

by Burnshield (pty) Ltd

Identity

Trade Name
Burnshield FDA UDI
Generic Name
Cotton burn sheet FDA UDI
Device Name
BURNSHIELD TWIN BLANKET 1.2X1.6M FDA UDI
Model / Reference
881002 FDA UDI
Description
BURNSHIELD TWIN BLANKET 1.2X1.6M FDA UDI

Identifiers

Catalog Number
881002 FDA UDI
Primary DI / UDI-DI
06007645002073 FDA UDI
510(k) Number
K943728 FDA UDI
FDA Product Code
MGQ FDA UDI
GMDN Term
Cotton burn sheet 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

No

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

Dimensions & Sizes

Size
Weight — 4500 Gram FDA UDI
Width — 1600 Millimeter FDA UDI
Length — 1200 Millimeter FDA UDI

Category: Cotton burn sheet

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

Similar devices

Also classified as Cotton burn sheet.

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 61cb9d68-f635-4620-81cc-372626d4186a 38 fields · synced May 30, 2026