Sigma

FDA UDI

Class III (US FDA UDI)

by Depuy (ireland)

Identity

Trade Name: SIGMA FDA UDI
Generic Name: Tibial insert FDA UDI
Device Name: SIGMA TIBIAL INSERT ROTATING PLATFORM TC3 SIZE 2.5 15mm GVF FDA UDI
Model / Reference: 96-2333 FDA UDI
Description: SIGMA TIBIAL INSERT ROTATING PLATFORM TC3 SIZE 2.5 15mm GVF FDA UDI

Identifiers

Catalog Number: 962333 FDA UDI
Primary DI / UDI-DI: 10603295242147 FDA UDI
FDA Product Code: NJL FDA UDI
GMDN Term: Tibial insert FDA UDI

Classification

Device Class: Class III 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Tibial insert

Sigma by Depuy (ireland) — Class III — 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 III	Pending data

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Manufacturer

Manufacturer: Depuy (ireland)

Sources (1)

FDA UDI a0bda6cc-788e-4e6e-83ec-1928037fb6b5 35 fields · synced May 31, 2026