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Surgify Halo | 4.0 mm | Extendable 40.000.SEE.U1

by Surgify Medical Oy

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06429811532281 UDI-DI Date31 Mar 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  • Withdrawn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
Surgify Halo | 4.0 mm | Extendable
Generic Name
Orthopaedic bur, single-use
Model / Reference
40.000.SEE.U1
Primary DI / UDI-DI
06429811532281
FDA Product Code
HBE
GMDN Term
Orthopaedic bur, single-use
Device Class
Class II
Regulation Number
882.4310
GUDID distribution status
In Commercial Distribution

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No