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TMC PSI Cut Guide System

FDA UDI

Class II (US FDA UDI)

by Treace Medical Concepts, Inc.

Identity

Trade Name
TMC PSI Cut Guide System FDA UDI
Generic Name
Custom-made orthopaedic/craniofacial surgical guide FDA UDI
Device Name
Cut Guide FDA UDI
Model / Reference
PSI-02-00386 FDA UDI
Description
Cut Guide FDA UDI

Identifiers

Primary DI / UDI-DI
00810111224680 FDA UDI
FDA Product Code
PBF FDA UDI
GMDN Term
Custom-made orthopaedic/craniofacial surgical guide FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Custom-made orthopaedic/craniofacial surgical guide

TMC PSI Cut Guide System by Treace Medical Concepts, Inc. — Class II — 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
Treace Medical Concepts, Inc.

Sources (1)

  • FDA UDI d6cf1b68-b6f1-4a6f-b3e9-639e90a739d3 33 fields · synced Jun 1, 2026