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ACRA-CUT 11/7mm DGR-II Mini

by Acra-Cut Inc

Ref 200-253Model 200-253 DGR-II

ACRA-CUT 11/7mm DGR-II Mini (200-253) is a medical device (EU MDD Class IIa; FDA Class II; FDA product code HBF, Drills, Burrs, Trephines & Accessories (Compound, Powered); EMDN category cranial perforators) made by Acra-Cut Inc, registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI B-00810607000057), cleared under FDA 510(k) K833266 on 29 Dec 1983 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00810607000057), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K833266

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00810607000057 Basic UDI-DI 00810607000057UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810607000057 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK833266 Date29 Dec 1983DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00810607000057 registered 6 Nov 2026 Active
  • FDA 510(k) K833266 decided 29 Dec 1983 Active
  • FDA GUDID UDI-DI 00810607000057 listed 23 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K833266
  2. Listed FDA GUDID 00810607000057
  3. Registered EUDAMED B-00810607000057

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Acra-Cut
Disposable Cranial Perforator
Generic name
Automatic cranial perforator, single-use
Cranial trephine, single-use
Model / Ref / Catalog
200-253 DGR-II, 200-253, 11/7mm DGR-II Mini, 200-253 11/7 mm, 200-253 DGR -II
Primary DI / UDI-DI
00810607000057, 00810607002532
Basic UDI-DI
B-00810607000057
510(k) Number
FDA product code
HBF
EMDN code
P091304 Cranial perforators, single-use
GMDN term
Automatic cranial perforator, single-use
Cranial trephine, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4305
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
200-253 DGR-II
200-253
GUDID
11/7mm DGR-II Mini
200-253 11/7 mm
Device classEUDAMED
Class IIa
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
No
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 00810607000057: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Automatic cranial perforator, single-use

Similar devices in this category

Other devices filed under CRANIAL PERFORATORS, SINGLE-USE.

Other devices from Acra-Cut Inc

See all devices from Acra-Cut Inc →

Properties

  • Supplied sterile
  • Sterilise before use NoEUDAMEDGUDIDYesGUDID
  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date YesGUDIDNoGUDID
Other properties (19, all answered No)