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P.f.c. Sigma Rpf

FDA UDI

Class I (US FDA UDI)

by Depuy International Ltd

Identity

Trade Name
P.F.C. SIGMA RPF FDA UDI
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Device Name
P.F.C. SIGMA RPF FEMORAL DISTRACTOR S-SHAPED FDA UDI
Model / Reference
95-9001 FDA UDI
Description
P.F.C. SIGMA RPF FEMORAL DISTRACTOR S-SHAPED FDA UDI

Identifiers

Catalog Number
959001 FDA UDI
Primary DI / UDI-DI
10603295231301 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

P.f.c. Sigma Rpf by Depuy International Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic prosthesis implantation positioning instrument, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Depuy International Ltd

Sources (1)

  • FDA UDI 9f8d823e-516f-4869-97fb-b58f72c19092 35 fields · synced May 30, 2026