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Medfix

FDA UDI

Class I (US FDA UDI)

by Medfix International, LLC

Identity

Trade Name
Medfix FDA UDI
Generic Name
Surgical instrument assist arm system, manually-adjusted FDA UDI
Device Name
Medfix® Rigid Articulating Arm, L-Column, Square QC Adaptor FDA UDI
Model / Reference
MF112-0150 FDA UDI
Description
Medfix® Rigid Articulating Arm, L-Column, Square QC Adaptor FDA UDI

Identifiers

Primary DI / UDI-DI
00810021830674 FDA UDI
FDA Product Code
MDM FDA UDI
GMDN Term
Surgical instrument assist arm system, manually-adjusted 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical instrument assist arm system, manually-adjusted

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

Similar devices

Also classified as Surgical instrument assist arm system, manually-adjusted.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 4e6e557b-1507-4bb1-9e85-2ba70a286fcf 34 fields · synced Jun 9, 2026