Tecomet

FDA UDI

Class I (US FDA UDI)

by Tecomet, Inc

Identity

Trade Name: Tecomet FDA UDI
Generic Name: Surgical instrument handle, torque-limiting FDA UDI
Device Name: TORQUE-LIMITING, LARGE-T 4.5mm HEX 106LBS.-IN. BLUE ORTHO-GRIP™ FDA UDI
Model / Reference: TL131106-J FDA UDI
Description: TORQUE-LIMITING, LARGE-T 4.5mm HEX 106LBS.-IN. BLUE ORTHO-GRIP™ FDA UDI

Identifiers

Primary DI / UDI-DI: 00841435106161 FDA UDI
FDA Product Code: HXX FDA UDI
GMDN Term: Surgical instrument handle, torque-limiting FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical instrument handle, torque-limiting

Tecomet by Tecomet, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Calibrate — ALPHATEC SPINE, INC. · Class I
ORTHROS — CAMBER SPINE TECHNOLOGIES · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Tecomet, Inc

Sources (1)

FDA UDI 67433f4f-1c73-42e8-bd8d-be3ad740fb96 33 fields · synced Sep 18, 2026