Kmedic

FDA UDI

Class I (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name: KMEDIC FDA UDI
Generic Name: Manual goniometer FDA UDI
Device Name: BONE COMPASS 8" FDA UDI
Model / Reference: IPN014544 FDA UDI
Description: BONE COMPASS 8" FDA UDI

Identifiers

Catalog Number: KM48302 FDA UDI
Primary DI / UDI-DI: 24026704278842 FDA UDI
FDA Product Code: GFI FDA UDI
GMDN Term: Manual goniometer 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 — 20.3 Centimeter FDA UDI

Category: Manual goniometer

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

Similar devices

Also classified as Manual goniometer.

INSTRUMENT — Howmedica Osteonics Corp. · Class I
Ambler Surgical — Ambler Surgical, LLC · Class I
Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
DEPUY — DEPUY ORTHOPAEDICS, INC. · Class I
GONIOMETER INTL STD 12.5IN — AliMed, LLC · Class I
gSource — GSOURCE, LLC. · Class I
TC-100 — Smith & Nephew, Inc. · Class II
TC-100 — Smith & Nephew, Inc. · Class II

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 cd4234bb-8a77-4a5f-9e14-11f49d498037 36 fields · synced Jun 8, 2026