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PyroCarbon PIP Total Joint System

FDA UDI

Class Unclassified (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
PyroCarbon PIP Total Joint System FDA UDI
Generic Name
Proximal interphalangeal joint prosthesis, modular FDA UDI
Device Name
PIP SZ. 10 DISTAL FDA UDI
Model / Reference
PIP-200-10D-WW FDA UDI
Description
PIP SZ. 10 DISTAL FDA UDI

Identifiers

Catalog Number
PIP-200-10D-WW FDA UDI
Primary DI / UDI-DI
00885556858394 FDA UDI
PMA Number
H010005 FDA UDI
FDA Product Code
OMX FDA UDI
GMDN Term
Proximal interphalangeal joint prosthesis, modular FDA UDI

Classification

Device Class
Unclassified 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: Proximal interphalangeal joint prosthesis, modular

PyroCarbon PIP Total Joint System by Smith & Nephew, Inc. — Class Unclassified — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Proximal interphalangeal joint prosthesis, modular.

Cleared under the same submission

H010005 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smith & Nephew, Inc.

Sources (1)

  • FDA UDI 3b80ade9-5327-4381-9813-a13e5b7901d3 36 fields · synced Jun 8, 2026