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PyroCarbon Lunate

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
PyroCarbon Lunate FDA UDI
Generic Name
Carpometacarpal interpositional spacer prosthesis trial FDA UDI
Device Name
LUNATE TRIAL SZ. 05 FDA UDI
Model / Reference
TRL-715-05T FDA UDI
Description
LUNATE TRIAL SZ. 05 FDA UDI

Identifiers

Catalog Number
TRL-715-05T FDA UDI
Primary DI / UDI-DI
00885556858868 FDA UDI
FDA Product Code
KWN FDA UDI
GMDN Term
Carpometacarpal interpositional spacer prosthesis trial FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3750 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

No

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: Carpometacarpal interpositional spacer prosthesis trial

PyroCarbon Lunate by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Carpometacarpal interpositional spacer prosthesis trial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smith & Nephew, Inc.

Sources (1)

  • FDA UDI aff34d57-cb72-42c9-902b-4788b9d8d96c 35 fields · synced Jun 8, 2026