Emphasys

FDA UDI

Class II (US FDA UDI)

by Depuy (ireland)

Identity

Trade Name: EMPHASYS FDA UDI
Generic Name: Orthopaedic broach FDA UDI
Device Name: EMPHASYS STARTER FEMORAL BROACH FDA UDI
Model / Reference: 4840-00-100 FDA UDI
Description: EMPHASYS STARTER FEMORAL BROACH FDA UDI

Identifiers

Catalog Number: 484000100 FDA UDI
Primary DI / UDI-DI: 10603295515562 FDA UDI
FDA Product Code: QBO FDA UDI
GMDN Term: Orthopaedic broach FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.4505 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic broach

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

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iNSitu™ Hip System — Nextstep Arthropedix · Class I
TEMA Elbow — Limacorporate · Class II

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 1cc95b29-9545-4bf1-9aec-a9b82d3474fe 35 fields · synced May 30, 2026