TruTORQ Offset T-Handle Sterile, Single Use 803-005

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 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00850078396389 UDI-DI	Date20 Oct 2026Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: TruTORQ Offset T-Handle Sterile, Single Use
Generic Name: Orthopaedic surgical procedure kit, non-medicated, single-use
Model / Ref / Catalog: 803-005

Primary DI / UDI-DI: 00850078396389
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

TruPWR Torque Limiting Attachment Sterile, Single Use 90 in-lb 228-TXRX-010

Class I
PFT Adapter, DS, Mariner, 105 in-lb (228-TXRX-009)

Class I
PFT Adapter, DS, Virata, 85 in-lb (228-TXRX-008)

Class I
SYNQ Single-Use Instrument System(1066)

Class I
Pecaplasty Wires First Single Use kit(1052)

Class I
PecaPusher(1061)

Class I

See all devices from Eca Medical Instruments →

Properties

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

Other properties (7)

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