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Emphasys

FDA UDI

Class II (US FDA UDI)

by Depuy (ireland)

Identity

Trade Name
EMPHASYS FDA UDI
Generic Name
Coated femoral stem prosthesis, one-piece FDA UDI
Device Name
EMPHASYS 12/14 FEMORAL STEM COLLARED HIGH OFFSET HA COATED 3 HO FDA UDI
Model / Reference
4742-03-200 FDA UDI
Description
EMPHASYS 12/14 FEMORAL STEM COLLARED HIGH OFFSET HA COATED 3 HO FDA UDI

Identifiers

Catalog Number
474203200 FDA UDI
Primary DI / UDI-DI
10603295505549 FDA UDI
FDA Product Code
KWL FDA UDI
KWY FDA UDI
MEH FDA UDI
LZO FDA UDI
GMDN Term
Coated femoral stem prosthesis, one-piece FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3360 FDA UDI
888.3390 FDA UDI
888.3353 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
MRI Safety
MR Conditional FDA UDI

Category: Coated femoral stem prosthesis, one-piece

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

Similar devices

Also classified as Coated femoral stem prosthesis, one-piece.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Depuy (ireland)

Sources (1)

  • FDA UDI 6a831f89-1852-4f6e-a851-cad49c9827fc 35 fields · synced Jun 6, 2026