Kmedic

FDA UDI

Class I (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name: KMEDIC FDA UDI
Generic Name: Bone hook FDA UDI
Device Name: RETRACTOR BLOUNT 1 PRONG 10.5" FDA UDI
Model / Reference: IPN014494 FDA UDI
Description: RETRACTOR BLOUNT 1 PRONG 10.5" FDA UDI

Identifiers

Catalog Number: KM48202 FDA UDI
Primary DI / UDI-DI: 24026704278095 FDA UDI
FDA Product Code: GAD FDA UDI
GMDN Term: Bone hook 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 — 3.7 Centimeter FDA UDI
Length — 26.5 Centimeter FDA UDI

Category: Bone hook

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

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Also classified as Bone hook.

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Ambler Surgical — Ambler Surgical, LLC · Class I
Novo Surgical Inc — NOVO SURGICAL, INC. · Class I
AESCULAP — AESCULAP, INC. · Class I
MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
GELPI NEROMA RETRACTOR — SONTEC INSTRUMENTS, 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

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Manufacturer

Manufacturer: Teleflex Incorporated

Sources (1)

FDA UDI 871d5a3e-a9b9-44fd-9ec8-64fc8b9ea826 36 fields · synced Jun 8, 2026