Kmedic

FDA UDI

Class I (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name: KMEDIC FDA UDI
Generic Name: Orthopaedic chisel FDA UDI
Device Name: LEXER CHISEL, 8 3/4", 5 MILLIMETER FDA UDI
Model / Reference: IPN014767 FDA UDI
Description: LEXER CHISEL, 8 3/4", 5 MILLIMETER FDA UDI

Identifiers

Catalog Number: KM49246 FDA UDI
Primary DI / UDI-DI: 24026704281453 FDA UDI
FDA Product Code: FZO FDA UDI
GMDN Term: Orthopaedic chisel 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

Dimensions & Sizes

Size: Width — 27 Millimeter FDA UDI
Length — 22 Centimeter FDA UDI

Category: Orthopaedic chisel

Kmedic by Teleflex Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic chisel.

Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
Ambler Surgical — Ambler Surgical, LLC · Class I
Gimmi — Gimmi GmbH · Class I
CHISEL — KLS-Martin L.P. · Class I
Ambler Surgical — Ambler Surgical, LLC · Class I
gSource — GSOURCE, LLC. · Class I
Ambler Surgical — Ambler Surgical, LLC · Class I
Novo Surgical — NOVO SURGICAL, INC. · 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Teleflex Incorporated

Sources (1)

FDA UDI 96550069-a77d-4290-8ee5-bdffb2cf4035 36 fields · synced Jun 6, 2026