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838365

by Richard Wolf GmbH

Ref 8383.65Model 10000277704

838365 (8383.65) is a Class I device made by Richard Wolf GmbH, registered in EUDAMED on 5 Oct 2026 (Basic UDI-DI B-04055207040119) and listed in FDA GUDID since 9 Aug 2022 (UDI-DI 04055207040119), active as of 23 Oct 2026.

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

CE MDD

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/MDD EUDAMED NumberB-04055207040119 Basic UDI-DI 04055207040119UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207040119 UDI-DI Date9 Aug 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04055207040119 registered 5 Oct 2026 Active
  • FDA GUDID UDI-DI 04055207040119 listed 9 Aug 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207040119
  2. Registered EUDAMED B-04055207040119

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
General-purpose endoscopic needle, reusable
Device name
Reusable cannulas
Model / Ref / Catalog
10000277704, 8383.65, 838365
Description
CANNULA FOR INJECTION Ø 4.7MM WL 350MM tip Ø 1.8mm, with 3mm Luer connection, reusable
Primary DI / UDI-DI
04055207040119
Basic UDI-DI
B-04055207040119
FDA product code
GEA
EMDN code
L1207 Laparoscopic and thoracoscopic surgery cannulas, reusable
GMDN term
General-purpose endoscopic needle, reusable
Device class
Class I
Regulation number
878.4800
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 4.7 Millimeter
Length — 350 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
10000277704
8383.65
GUDID
838365

Related devices

Category: General-purpose endoscopic needle, reusable

Similar devices in this category

Other devices filed under LAPAROSCOPIC AND THORACOSCOPIC SURGERY INSTRUMENTS, REUSABLE.

Other devices from Richard Wolf GmbH

See all devices from Richard Wolf GmbH →

Properties

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