Emphasys

FDA UDI

Class II (US FDA UDI)

by Depuy (ireland)

Identity

Trade Name: EMPHASYS FDA UDI
Generic Name: Acetabular shell FDA UDI
Device Name: EMPHASYS ACETABULAR SHELL NO-HOLE 58MM FDA UDI
Model / Reference: 4710-58-000 FDA UDI
Description: EMPHASYS ACETABULAR SHELL NO-HOLE 58MM FDA UDI

Identifiers

Catalog Number: 471058000 FDA UDI
Primary DI / UDI-DI: 10603295503095 FDA UDI
FDA Product Code: LZO FDA UDI
LPH FDA UDI
GMDN Term: Acetabular shell FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 FDA UDI
888.3358 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: Acetabular shell

Emphasys 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 702b421c-7e33-4a78-b434-94c93230ea50 35 fields · synced May 29, 2026