Kmedic

FDA UDI

Class I (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name: KMEDIC FDA UDI
Generic Name: Orthopaedic chisel blade FDA UDI
Device Name: CHISEL BLADE 25 MILLIMETER STRAIGHT FOR KM49-630 FDA UDI
Model / Reference: IPN014844 FDA UDI
Description: CHISEL BLADE 25 MILLIMETER STRAIGHT FOR KM49-630 FDA UDI

Identifiers

Catalog Number: KM49664 FDA UDI
Primary DI / UDI-DI: 24026704282283 FDA UDI
FDA Product Code: GFI FDA UDI
GMDN Term: Orthopaedic chisel blade 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: Length — 81.3 Millimeter FDA UDI
Width — 25 Millimeter FDA UDI

Category: Orthopaedic chisel blade

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

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CHISEL OSTEOTOME BLADE 76x8 WITH HOLE — HPF SRL · Class I
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Buxton BioMedical — BUXTON BIOMEDICAL, INC. · Class I
Intramedullary Internal Chisel — Biomet Orthopedics, Inc. · Class I
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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: Teleflex Incorporated

Sources (1)

FDA UDI 8fc8c12f-8379-4a5e-8e63-758233d36b82 36 fields · synced Jun 1, 2026