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Burnshield 881002

by Burnshield (Pty) Ltd

Burnshield 881002 is a device classified as Unclassified made by Burnshield (Pty) Ltd, cleared under FDA 510(k) K943728 on 27 Sep 1994 and listed in FDA GUDID since 1 Nov 2018 (UDI-DI 06007645002073), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K943728

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06007645002073 UDI-DI Date1 Nov 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SN from GUDID Traditional NumberK943728 Date27 Sep 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K943728 decided 27 Sep 1994 Active
  • FDA GUDID UDI-DI 06007645002073 listed 1 Nov 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K943728
  2. Listed FDA GUDID 06007645002073

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Burnshield
Generic name
Cotton burn sheet
Model / Ref / Catalog
881002
Primary DI / UDI-DI
06007645002073
FDA product code
MGQ
GMDN term
Cotton burn sheet
Device class
U
GUDID distribution status
In Commercial Distribution
Size
Weight — 4500 Gram
Width — 1600 Millimeter
Length — 1200 Millimeter

Similar devices

Other devices filed under FDA product code MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic).

Other devices from Burnshield (Pty) Ltd

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Properties

  • Supplied sterile
  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)