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8383552

by Richard Wolf GmbH

Ref 8383.552Model 10000201228

8383552 (8383.552) is a Class I device made by Richard Wolf GmbH, registered in EUDAMED on 1 Sep 2026 (Basic UDI-DI B-04055207015063) and listed in FDA GUDID since 8 Aug 2024 (UDI-DI 04055207015063), 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-04055207015063 Basic UDI-DI 04055207015063UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207015063 UDI-DI Date8 Aug 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04055207015063 registered 1 Sep 2026 Active
  • FDA GUDID UDI-DI 04055207015063 listed 8 Aug 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207015063
  2. Registered EUDAMED B-04055207015063

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  • Withdrawn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, 8383.552, 8383552
Description
KNOT PUSHER Ø 5MM WL 330MM by Buess, with distal notch and lateral opening, atraumatic tip for use as a probe, TL 380mm, for extracorporeal knots, reusable
Primary DI / UDI-DI
04055207015063
Basic UDI-DI
B-04055207015063
FDA product code
NWV
EMDN code
L0207 Knot pushers, reusable
GMDN term
Suture knot pusher, reusable
Device class
Class I
Regulation number
884.1720
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 — 5 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
10000201228
8383.552
GUDID
8383552

Similar devices in this category

Other devices filed under SUTURE INSTRUMENTS, REUSABLE.

Other devices from Richard Wolf GmbH

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Properties

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