Medfix

FDA UDI

Class I (US FDA UDI)

by Medfix International, LLC

Identity

Trade Name: Medfix FDA UDI
Generic Name: Nerve/vessel retractor FDA UDI
Device Name: Medfix® Scoville Nerve Root Retractor, 8.0 mm Wide, 9" (23.0 cm), Angled FDA UDI
Model / Reference: MF229-5187 FDA UDI
Description: Medfix® Scoville Nerve Root Retractor, 8.0 mm Wide, 9" (23.0 cm), Angled FDA UDI

Identifiers

Primary DI / UDI-DI: 00810021834122 FDA UDI
FDA Product Code: GAD FDA UDI
GMDN Term: Nerve/vessel retractor 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: Nerve/vessel retractor

Medfix by Medfix International, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nerve/vessel retractor.

Ambler Surgical — Ambler Surgical, LLC · Class I
BOSS Instruments — Boss Instruments, Ltd. · Class I
Life Instruments — Life Instrument Corporation · Class I
Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
JACOBSON SHEPARDS HOOK PROBE — SONTEC INSTRUMENTS, INC. · Class I
Avalign — AVALIGN TECHNOLOGIES, Inc. · Class I
Integra® Ruggles®-Redmond™ — Integra LifeSciences Production Corporation · Class I
RAVINE Lateral Access System — K2M, 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Medfix International, LLC

Sources (1)

FDA UDI ba73a2ba-f5c7-4096-a9df-44e49167f9c7 34 fields · synced Jun 9, 2026