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Universal 2™ Total Wrist Implant System

FDA UDI

Class I (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name
Universal 2™ Total Wrist Implant System FDA UDI
Generic Name
Custom-made orthopaedic/craniofacial surgical guide FDA UDI
Device Name
Universal 2™ Total Wrist Implant System CARPAL CUTTING GUIDE FDA UDI
Model / Reference
268340 FDA UDI
Description
Universal 2™ Total Wrist Implant System CARPAL CUTTING GUIDE FDA UDI

Identifiers

Catalog Number
268340 FDA UDI
Primary DI / UDI-DI
10381780278832 FDA UDI
FDA Product Code
FZX FDA UDI
GMDN Term
Custom-made orthopaedic/craniofacial surgical guide 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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Custom-made orthopaedic/craniofacial surgical guide

Universal 2™ Total Wrist Implant System by Ascension Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Custom-made orthopaedic/craniofacial surgical guide.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ascension Orthopedics, Inc.

Sources (1)

  • FDA UDI 295dd9cf-36e9-46e1-a7d6-d140b7bd13f2 37 fields · synced May 31, 2026