P.f.c. Sigma

FDA UDI

Class III (US FDA UDI)

by Depuy (ireland)

Identity

Trade Name: P.F.C. SIGMA FDA UDI
Generic Name: Polyethylene patella prosthesis FDA UDI
Device Name: P.F.C. SIGMA INSET PATELLA 32mm CEMENTED FDA UDI
Model / Reference: 96-0122 FDA UDI
Description: P.F.C. SIGMA INSET PATELLA 32mm CEMENTED FDA UDI

Identifiers

Catalog Number: 960122 FDA UDI
Primary DI / UDI-DI: 10603295232766 FDA UDI
FDA Product Code: NJL FDA UDI
JWH FDA UDI
GMDN Term: Polyethylene patella prosthesis FDA UDI

Classification

Device Class: Class III 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Polyethylene patella prosthesis

P.f.c. Sigma by Depuy (ireland) — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Proven Gen-Flex PS Knee System — GLOBUS MEDICAL, INC. · Class II
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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 0a90894b-2d80-4587-8f77-bcb1062bf4fd 35 fields · synced May 30, 2026