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Bent Rasp

by Limacorporate

Ref 9095.10.162Model 80333901R003ES, Bent Rasp

Bent Rasp (9095.10.162) is a device classified as Class I in the EU and Class II in the US made by Limacorporate, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI 80333901R003ES), cleared under FDA 510(k) K141327 on 6 Aug 2014 and listed in FDA GUDID since 5 Aug 2016 (UDI-DI 08033390083935), active as of 7 Nov 2026.

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

CE MDR 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) K141327

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 Number80333901R003ES Basic UDI-DI 08033390083935UDI-DIDate29 Oct 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED Number80333901R003ES Basic UDI-DI 08033390083935UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08033390083935 UDI-DI Date5 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK141327 Date6 Aug 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 80333901R003ES registered 29 Oct 2026 Active· +1 more in the status table
  • FDA 510(k) K141327 decided 6 Aug 2014 Active
  • FDA GUDID UDI-DI 08033390083935 listed 5 Aug 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K141327
  2. Listed FDA GUDID 08033390083935
  3. Registered EUDAMED 80333901R003ES

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Bone file/rasp, manual, reusable
Model / Ref / Catalog
Bent Rasp, 80333901R003ES, 9095.10.162
Primary DI / UDI-DI
08033390083935
Basic UDI-DI
80333901R003ES, B-08033390083935
510(k) Number
FDA product code
KWY, LZO, JDI, KWZ, LPH, MBL
EMDN code
L091201 Orthopaedic surgery rasps, reusable
GMDN term
Bone file/rasp, manual, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3390, 888.3353, 888.3350, 888.3310, 888.3358
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Bone file/rasp, manual, reusable

Cleared under the same submission (K141327)

and 8 more cleared under K141327

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY RASPS, REUSABLE.

Other devices from Limacorporate

See all devices from Limacorporate →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)