Tecomet

FDA UDI

Class I (US FDA UDI)

by Tecomet, Inc

Identity

Trade Name: Tecomet FDA UDI
Generic Name: Orthopaedic joint/limb rongeur FDA UDI
Device Name: LEXELL RONGEUR 9" 15° CURVED 7X16MM FDA UDI
Model / Reference: KMPR1725 FDA UDI
Description: LEXELL RONGEUR 9" 15° CURVED 7X16MM FDA UDI

Identifiers

Primary DI / UDI-DI: 00841435108608 FDA UDI
FDA Product Code: GAD FDA UDI
GMDN Term: Orthopaedic joint/limb rongeur FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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: Orthopaedic joint/limb rongeur

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

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MICRO FRIEDMAN RONGEUR — SONTEC INSTRUMENTS, INC. · Class I
Sklar® — Sklar Corporation · 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 9465d634-ca82-4f32-a5cd-cdd633e1d146 33 fields · synced Sep 18, 2026