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Phasor Drill 1

by Biotex, Inc.

Phasor Drill 1, a craniotomy power tool system (FDA Class II; FDA product code HBE, Drills, Burrs, Trephines & Accessories (Simple, Powered)) made by Biotex, Inc., was listed in FDA GUDID on 16 Oct 2017 (UDI-DI M710008102804); the registry lists it as not in commercial distribution (GUDID) as of 23 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

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 NumberM710008102804 UDI-DI Date16 Oct 2017ListedStatusListed GUDID: not 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  • Withdrawn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
Phasor Drill
Generic name
Craniotomy power tool system, battery-powered, single-use
Model / reference
1
Primary DI / UDI-DI
M710008102804
FDA product code
HBE
GMDN term
Craniotomy power tool system, battery-powered, single-use
Device class
Class II
Regulation number
882.4310
GUDID distribution status
Not in Commercial Distribution
Sterilisation method
Radiation Sterilization
MRI safety
MR Unsafe

Similar devices

Other devices filed under FDA product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)).

Other devices from Biotex, Inc.

See all devices from Biotex, Inc. →

Properties

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