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Patella Double #3 Scalpel Handle 12mm

by Innomed, Inc. EUDAMEDGUDID

Active European Union

Ref 8207-01

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00840277133762 UDI-DIDate12 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8402771INNOEXTRACT0188 Basic UDI-DIDate18 Mar 2022RegisteredStatusActive

Coverage

2 jurisdictions

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  • Withdrawn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

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Patella Double #3 Scalpel Handle 12mm EUDAMED
Innomed, Inc. GUDID
Generic Name
Orthopaedic inorganic implant inserter/extractor, reusable
Device Name
Extractor
Model / Ref / Catalog
8207-01
Primary DI / UDI-DI
00840277133762
Basic UDI-DI
8402771INNOEXTRACT0188
Direct Marketing DI
00840277133762
FDA Product Code
HWB
EMDN Code
L0921 Non-implantable orthopaedic devices extractors, reusable
GMDN Term
Orthopaedic inorganic implant inserter/extractor, reusable
Device Class
Class I
Regulation Number
888.4540
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
US-MF-000014761
Authorised representative
MediMark Europe Sarl. FR-AR-000000182

Other devices from Innomed, Inc.

See all devices from Innomed, Inc. →

Properties

  • Reusable
  • Premarket Exempt

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No