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Reinert Reduction Instrument, 10.5mm, Low Profile

by Starr Frame LLC

Ref SF-8800-5017Model SF-8800-5015

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

CE MDR

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/MDR EUDAMED Number0854226007INSTRUMENTSPA Basic UDI-DI 00854226007189UDI-DIDate20 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00854226007189 UDI-DI Date18 Nov 2022ListedStatusListed GUDID: 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Reinert Reduction Instrument, 10.5mm, Low Profile EUDAMED
Reinert Reduction Tool, 10.5mm, Low Profile GUDID
Generic Name
Bone lever/elevator, reusable
Device Name
Reinert Reduction Tool, 10.5mm
Model / Ref / Catalog
SF-8800-5015, SF-8800-5017
Primary DI / UDI-DI
00854226007189
Basic UDI-DI
0854226007INSTRUMENTSPA
FDA Product Code
LXH
EMDN Code
L0908 Orthopaedic and traumatological traction instruments, reusable
GMDN Term
Bone lever/elevator, reusable
Device Class
Class I
Regulation Number
888.4540
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
US-MF-000047790
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Starr Frame LLC

See all devices from Starr Frame LLC →

Properties

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

Other properties (20)

  • 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
  • Serial Number: No
  • Expiration Date: No