iTotal CR

FDA UDI

Class II (US FDA UDI)

by Conformis, Inc.

Identity

Trade Name: iTotal CR FDA UDI
Generic Name: Tibial insert FDA UDI
Device Name: ITOTAL CR–IPOLY XE–14MM MEDIAL INSERT KIT–LEFT or right FDA UDI
Model / Reference: RCR-020-140003 FDA UDI
Description: ITOTAL CR–IPOLY XE–14MM MEDIAL INSERT KIT–LEFT or right FDA UDI

Identifiers

Catalog Number: RCR-020-1400 FDA UDI
Primary DI / UDI-DI: M572RCR0201400031 FDA UDI
FDA Product Code: JWH FDA UDI
OOG FDA UDI
OIY FDA UDI
GMDN Term: Tibial insert 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

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Tibial insert

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Conformis, Inc.

Sources (1)

FDA UDI ccc9cf56-b421-48fb-9665-191876b5e0d1 36 fields · synced Jun 1, 2026