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Synthes 316.288

by Provision

Synthes 316.288 is a Class I device made by Provision, listed in FDA GUDID since 20 Jul 2026 (UDI-DI B504OM3162880), 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 NumberB504OM3162880 UDI-DI Date20 Jul 2026ListedStatusListed 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  • Withdrawn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
Synthes
Generic name
Fluted surgical drill bit, single-use
Model / reference
316.288
Primary DI / UDI-DI
B504OM3162880
FDA product code
HTW
GMDN term
Fluted surgical drill bit, single-use
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution

Other devices from Provision

See all devices from Provision →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)