← Back to catalogue

Freedom Wrist Arthroplasty System

FDA UDI

Class I (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
Freedom Wrist Arthroplasty System FDA UDI
Generic Name
Osteotomy guide, reusable FDA UDI
Device Name
RADIAL RESECTION GUIDE SIZE 3 FDA UDI
Model / Reference
348145 FDA UDI
Description
RADIAL RESECTION GUIDE SIZE 3 FDA UDI

Identifiers

Catalog Number
348145 FDA UDI
Primary DI / UDI-DI
00885556855386 FDA UDI
FDA Product Code
FZX FDA UDI
GMDN Term
Osteotomy guide, 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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: Osteotomy guide, reusable

Freedom Wrist Arthroplasty System by Smith & Nephew, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Osteotomy guide, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Smith & Nephew, Inc.

Sources (1)

  • FDA UDI 77b9bd1e-4310-458c-86fa-de880eeed620 35 fields · synced Jun 8, 2026