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TruTORQ Medium Axial Handle, Sterile, Single Use, With T8 1010

by Eca Medical Instruments

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00857676008874 UDI-DI Date25 Feb 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
TruTORQ Medium Axial Handle, Sterile, Single Use, With T8
Generic Name
Orthopaedic surgical procedure kit, non-medicated, single-use
Model / Ref / Catalog
1010
Primary DI / UDI-DI
00857676008874
FDA Product Code
LXH
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, single-use
Device Class
Class I
Regulation Number
888.4540
GUDID distribution status
In Commercial Distribution

From the manufacturer

Manufacturer's product page: Why Single-Use?

Other devices from Eca Medical Instruments

See all devices from Eca Medical Instruments →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (6)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No