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Dukal 8512

by Dukal LLC

Dukal 8512 is a Class I device made by Dukal LLC, listed in FDA GUDID since 16 Sep 2026 (UDI-DI 20665973033185), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number20665973033185 UDI-DI Date16 Sep 2026ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Dukal
Generic name
Woven gauze pad, non-antimicrobial
Model / Ref / Catalog
8512
Description
Everyday Care Sponge 4" x 4", 8ply, Non-Sterile
Primary DI / UDI-DI
20665973033185
FDA product code
NAB
GMDN term
Woven gauze pad, non-antimicrobial
Device class
Class I
Regulation number
878.4014
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code NAB (Gauze / sponge,nonresorbable for external use).

Other devices from Dukal LLC

See all devices from Dukal LLC →

Properties

  • Single use
  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)