Skip to content

PMT Drill Cutter 2.2 x 20 mm

by adeor Medical AG

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04251388961278 UDI-DI Date2 Apr 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
PMT Drill Cutter
Generic Name
Cranial bur, single-use
Model / Ref / Catalog
2.2 x 20 mm, 2103-254
Primary DI / UDI-DI
04251388961278
510(k) Number
FDA Product Code
HBE
GMDN Term
Cranial bur, single-use
Device Class
Class II
Regulation Number
882.4310
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K130755)

Show all (12)

Other devices from adeor Medical AG

See all devices from adeor Medical AG →

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