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iTotal Identity CR

FDA UDI

Class II (US FDA UDI)

by Conformis, Inc.

Identity

Trade Name
iTotal Identity CR FDA UDI
Generic Name
Joint prosthesis implantation kit, single-use FDA UDI
Device Name
ITOTAL IDENTITY CR HYBRID JIGS, LEFT or right FDA UDI
Model / Reference
TCR-000-SPEC02 FDA UDI
Description
ITOTAL IDENTITY CR HYBRID JIGS, LEFT or right FDA UDI

Identifiers

Catalog Number
TCR-000-SPEC FDA UDI
Primary DI / UDI-DI
M572TCR000SPEC021 FDA UDI
FDA Product Code
JWH FDA UDI
OIY FDA UDI
OOG FDA UDI
GMDN Term
Joint prosthesis implantation kit, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3560 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Joint prosthesis implantation kit, single-use

iTotal Identity CR by Conformis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Joint prosthesis implantation kit, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Conformis, Inc.

Sources (1)

  • FDA UDI d678fdc6-3dfd-4c7d-8805-c322da8d7e26 35 fields · synced May 31, 2026