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Simpex Drill Bit DB-177-10

by Simpex Medical, Inc.

Simpex Drill Bit DB-177-10 is a Class I device made by Simpex Medical, Inc., listed in FDA GUDID since 18 Oct 2019 (UDI-DI B068DB177101), 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 NumberB068DB177101 UDI-DI Date18 Oct 2019ListedStatusListed 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  • Withdrawn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
Simpex Drill Bit
Generic name
Fluted surgical drill bit, single-use, non-sterile
Model / Ref / Catalog
DB-177-10
Primary DI / UDI-DI
B068DB177101
FDA product code
HTW
GMDN term
Fluted 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 — 4.5 Millimeter

Related devices

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

Similar devices in this category

Other devices filed under Fluted surgical drill bit, single-use, non-sterile.

Other devices from Simpex Medical, Inc.

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Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (10, all answered No)