Medfix

FDA UDI

Class I (US FDA UDI)

by Medfix International, LLC

Identity

Trade Name: Medfix FDA UDI
Generic Name: Bone lever/elevator, reusable FDA UDI
Device Name: Medfix® Freer Elevator, Double-Ended, Sharp & Blunt Blades, 7 1/2" (19.0 cm), 5.0 mm Wide FDA UDI
Model / Reference: MF303-3402 FDA UDI
Description: Medfix® Freer Elevator, Double-Ended, Sharp & Blunt Blades, 7 1/2" (19.0 cm), 5.0 mm Wide FDA UDI

Identifiers

Primary DI / UDI-DI: 00810021836485 FDA UDI
FDA Product Code: MDM FDA UDI
GMDN Term: Bone lever/elevator, reusable 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

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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone lever/elevator, reusable

Medfix by Medfix International, LLC — 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: Medfix International, LLC

Sources (1)

FDA UDI a5b3d14f-67f9-43d0-a25d-5dc53e573d2f 34 fields · synced Jun 9, 2026