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Hana/Profx Classic Femoral Hook Left, Refurbished 6850-140R

by Mizuho Orthopedic Systems, Inc.

Ref 6850-140

Active European Union. Also listed in GUDID (US), partly in commercial distribution.

CE MDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00842430106835 Basic UDI-DI 00842430106835UDI-DIDate18 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842430106835 UDI-DI Date12 Mar 2020ListedStatusListed GUDID: 1 of 2 UDI-DIs in commercial distribution

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.

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  • Withdrawn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

Trade Name
Hana/ProFx Classic Femoral Hook Left EUDAMEDGUDID
Hana/Profx Classic Femoral Hook Left, Refurbished GUDID
Generic Name
Bone lever/elevator, reusable
Model / Ref / Catalog
6850-140, 6850-140R
Primary DI / UDI-DI
00842430106835, 00842430103544
Basic UDI-DI
B-00842430106835
FDA Product Code
LXH
EMDN Code
L0902 Orthopaedic surgery levers, reusable
GMDN Term
Bone lever/elevator, reusable
Device Class
Class I
Regulation Number
888.4540
EU market of registration
Germany
GUDID distribution status
Not in Commercial Distribution (UDI-DI 00842430103544)
In Commercial Distribution (UDI-DI 00842430106835)
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from Mizuho Orthopedic Systems, Inc.

See all devices from Mizuho Orthopedic Systems, Inc. →

Properties

  • Reusable
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: 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
  • Serial Number: No
  • Expiration Date: No