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PyroSphere CMC

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
PyroSphere CMC FDA UDI
Generic Name
Metacarpal prosthesis FDA UDI
Device Name
PCS SZ. 40 PYROSPHERE FDA UDI
Model / Reference
PCS-430-40-WW FDA UDI
Description
PCS SZ. 40 PYROSPHERE FDA UDI

Identifiers

Catalog Number
PCS-430-40-WW FDA UDI
Primary DI / UDI-DI
00885556830772 FDA UDI
FDA Product Code
KYI FDA UDI
KWD FDA UDI
GMDN Term
Metacarpal prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3770 FDA UDI
888.3730 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: Metacarpal prosthesis

PyroSphere CMC by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metacarpal prosthesis.

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 896ebf2c-69f6-4272-b84c-71cfaa13787a 35 fields · synced Jun 8, 2026