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838355

by Richard Wolf GmbH

Ref 8383.55Model 10000201228

838355 (8383.55) is a device classified as Class I in the EU and Class II in the US made by Richard Wolf GmbH, registered in EUDAMED on 5 Oct 2026 (Basic UDI-DI B-04055207009833) and listed in FDA GUDID since 8 Feb 2024 (UDI-DI 04055207009833), 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-04055207009833 Basic UDI-DI 04055207009833UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207009833 UDI-DI Date8 Feb 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04055207009833 registered 5 Oct 2026 Active
  • FDA GUDID UDI-DI 04055207009833 listed 8 Feb 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207009833
  2. Registered EUDAMED B-04055207009833

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  • Withdrawn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
Suture knot pusher, reusable
Device name
Surgical knot pushers
Model / Ref / Catalog
10000201228, 8383.55, 838355
Description
KNOT PUSHER Ø 3.7MM WL 330MM TL 380mm, for intraabdominal knots, reusable
Primary DI / UDI-DI
04055207009833
Basic UDI-DI
B-04055207009833
FDA product code
GCJ
EMDN code
L0207 Knot pushers, reusable
GMDN term
Suture knot pusher, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500
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
Length — 330 Millimeter
Outer Diameter — 3.7 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
10000201228
8383.55
GUDID
838355
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: Suture knot pusher, reusable

Similar devices in this category

Other devices filed under SUTURE INSTRUMENTS, REUSABLE.

Other devices from Richard Wolf GmbH

See all devices from Richard Wolf GmbH →

Properties

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