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T-Handle Pivot Control

by TeDan Surgical Innovations, Inc.

Ref LS-0451

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 Number8430591RETRACTORTH Basic UDI-DI 00843059120219UDI-DIDate4 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00843059120219 UDI-DI Date10 Jan 2018ListedStatusListed 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  • Withdrawn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
T-Handle Pivot Control EUDAMED
Tsi GUDID
Generic Name
Self-retaining surgical retractor, reusable
Device Name
Retractor
Model / Reference
LS-0451
Primary DI / UDI-DI
00843059120219
Basic UDI-DI
8430591RETRACTORTH
Direct Marketing DI
00843059120219
FDA Product Code
GAD
EMDN Code
L03140199 Spreaders and retractors for general surgery, reusable - other
GMDN Term
Self-retaining surgical retractor, reusable
Device Class
Class I
Regulation Number
878.4800
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
US-MF-000016933
Authorised representative
TeDan Surgical Innovations B.V. NL-AR-000002696

Related devices

Category: Hand-held surgical retractor, reusable

Other devices from TeDan Surgical Innovations, Inc.

See all devices from TeDan Surgical Innovations, Inc. →

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