C-Stem

FDA UDI

Class II (US FDA UDI)

by Depuy (ireland)

Identity

Trade Name: C-STEM FDA UDI
Generic Name: Uncoated femoral stem prosthesis, one-piece FDA UDI
Device Name: C-STEM AMT Cemented Stem Standard Offset Size 4 12/14 TAPER FDA UDI
Model / Reference: 1570-04-100 FDA UDI
Description: C-STEM AMT Cemented Stem Standard Offset Size 4 12/14 TAPER FDA UDI

Identifiers

Catalog Number: 157004100 FDA UDI
Primary DI / UDI-DI: 10603295059639 FDA UDI
FDA Product Code: LZO FDA UDI
JDI FDA UDI
GMDN Term: Uncoated femoral stem prosthesis, one-piece FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 FDA UDI
888.3350 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: Uncoated femoral stem prosthesis, one-piece

C-Stem by Depuy (ireland) — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 II	Pending data

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Manufacturer

Manufacturer: Depuy (ireland)

Sources (1)

FDA UDI 9f007582-38ca-48b8-806f-d036b2083cb5 35 fields · synced May 30, 2026