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Aesculap OK509R

by Aesculap, Inc.

Part of a family of 14 devices: see the family page

Ref OK509R

Aesculap OK509R is a Class I device made by Aesculap, Inc., registered in EUDAMED on 17 Jun 2025 (Basic UDI-DI 40392390000003922D) and listed in FDA GUDID since 22 Apr 2020 (UDI-DI 04038653177295), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number40392390000003922D Basic UDI-DI 04038653177295UDI-DIDate17 Jun 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04038653177295 UDI-DI Date22 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 40392390000003922D registered 17 Jun 2025 Active
  • FDA GUDID UDI-DI 04038653177295 listed 22 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04038653177295
  2. Registered EUDAMED 40392390000003922D

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Aesculap
Generic name
Craniofacial rongeur, reusable
Device name
Ethmoid forceps
Model / Ref / Catalog
OK509R
Primary DI / UDI-DI
04038653177295
Basic UDI-DI
40392390000003922D
Direct marketing DI
04038653177295
FDA product code
KAE
EMDN code
L140202 Nasal and paranasal cavity surgery pliers, reusable
GMDN term
Craniofacial rongeur, reusable
Device class
Class I
Regulation number
874.4420
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices in this category

Other devices filed under NASAL AND PARANASAL CAVITY SURGERY PLIERS, REUSABLE.

Other devices from Aesculap, Inc.

See all devices from Aesculap, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)