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Phasor Drill 008-1043

by Biotex, Inc.

Phasor Drill 008-1043 (PH-580-70), a craniotomy power tool system (FDA Class I) made by Biotex, Inc., was listed in FDA GUDID on 30 Aug 2019 (UDI-DI M710PH580700); 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 NumberM710PH580700 UDI-DI Date30 Aug 2019ListedStatusListed 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  • Withdrawn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 / Ref / Catalog
008-1043, PH-580-70
Primary DI / UDI-DI
M710PH580700
FDA product code
GFG, KIJ, HBE
GMDN term
Craniotomy power tool system, battery-powered, single-use
Device class
Class I
Regulation number
878.4820, 882.4310
GUDID distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Size
Outer Diameter — 5.8 Millimeter

Similar devices

Other devices filed under FDA product code GFG (Bit, Surgical).

Other devices from Biotex, Inc.

See all devices from Biotex, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)