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Buxton BioMedical 56-8335

by Buxton Biomedical, Inc.

Buxton BioMedical 56-8335 is a Class I device made by Buxton Biomedical, Inc., listed in FDA GUDID since 1 Mar 2024 (UDI-DI B7685683350), 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 NumberB7685683350 UDI-DI Date1 Mar 2024ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Buxton BioMedical
Generic name
Surgical mallet
Model / Ref / Catalog
56-8335
Primary DI / UDI-DI
B7685683350
FDA product code
LXH
GMDN term
Surgical mallet
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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Properties

  • Sterilise before use
  • Premarket exempt
Other properties (13, all answered No)