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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
Tibial insert FDA UDI
Device Name
P.F.C. SIGMA TIBIAL INSERT ROTATING PLATFORM RP-F SIZE 4 15mm GVF FDA UDI
Model / Reference
95-1042 FDA UDI
Description
P.F.C. SIGMA TIBIAL INSERT ROTATING PLATFORM RP-F SIZE 4 15mm GVF FDA UDI

Identifiers

Catalog Number
951042 FDA UDI
Primary DI / UDI-DI
10603295230434 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

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

Category: Tibial insert

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

Similar devices

Also classified as Tibial insert.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Depuy (ireland)

Sources (1)

  • FDA UDI 953f76ee-e490-4792-a4d6-975930a8b2f9 35 fields · synced May 31, 2026