Kmedic

FDA UDI

Class I (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name: KMEDIC FDA UDI
Generic Name: Orthopaedic implant impactor, reusable FDA UDI
Device Name: IMPACTOR STANDARD OFFSET, 8 1/2" FDA UDI
Model / Reference: IPN015180 FDA UDI
Description: IMPACTOR STANDARD OFFSET, 8 1/2" FDA UDI

Identifiers

Catalog Number: KM55370 FDA UDI
Primary DI / UDI-DI: 24026704286229 FDA UDI
FDA Product Code: HWA FDA UDI
GMDN Term: Orthopaedic implant impactor, reusable 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

Dimensions & Sizes

Size: Length — 21.6 Centimeter FDA UDI

Category: Orthopaedic implant impactor, reusable

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

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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 e07c6c78-7071-4107-b9a4-0b6e101a47d4 36 fields · synced Jun 6, 2026