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OsteoMed 316-0534

by Osteomed Corp.

OsteoMed 316-0534 is a Class I device made by Osteomed Corp., listed in FDA GUDID since 27 Apr 2021 (UDI-DI 00842528126738), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00842528126738 UDI-DI Date27 Apr 2021ListedStatusListed 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  • Withdrawn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
OsteoMed
Generic name
Cannulated surgical drill bit, single-use, non-sterile
Model / Ref / Catalog
316-0534
Primary DI / UDI-DI
00842528126738
FDA product code
HTW
GMDN term
Cannulated surgical drill bit, single-use, non-sterile
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 2.7 Millimeter

Related devices

Category: Cannulated surgical drill bit, single-use, non-sterile

Similar devices

Other devices filed under FDA product code HTW (BIT, DRILL).

Other devices from Osteomed Corp.

See all devices from Osteomed Corp. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (9, all answered No)