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CeroFrict SML005-BB07

by SML Med-Tech Solutions Limited

CeroFrict SML005-BB07 is a Class I device made by SML Med-Tech Solutions Limited, listed in FDA GUDID since 11 Aug 2025 (UDI-DI 04897129991281), 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 Number04897129991281 UDI-DI Date11 Aug 2025ListedStatusListed 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  • Withdrawn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
CeroFrict
Generic name
Endoscopic bite block, basic, single-use
Model / reference
SML005-BB07
Primary DI / UDI-DI
04897129991281
FDA product code
MNK
GMDN term
Endoscopic bite block, basic, single-use
Device class
Class I
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

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Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)