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Phasor 6.35CK

by Phasor Health, LLC

Phasor 6.35CK is a Class II device made by Phasor Health, LLC, listed in FDA GUDID since 19 Jan 2026 (UDI-DI B775635CK0), 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 NumberB775635CK0 UDI-DI Date19 Jan 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  • Withdrawn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
Phasor
Generic name
Manual cranial rotary handpiece, single-use
Model / reference
6.35CK
Primary DI / UDI-DI
B775635CK0
FDA product code
HBG, OJG
GMDN term
Manual cranial rotary handpiece, single-use
Device class
Class II
Regulation number
882.4300, 882.4525
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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See all devices from Phasor Health, LLC →

Properties

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