Emphasys

FDA UDI

Class II (US FDA UDI)

by Depuy (ireland)

Identity

Trade Name: EMPHASYS FDA UDI
Generic Name: Instrument tray, reusable FDA UDI
Device Name: EMPHASYS ACETABULAR ALUMINUM CADDY TRIAL LINER 40OD - 46OD28ID FDA UDI
Model / Reference: 4800-60-028 FDA UDI
Description: EMPHASYS ACETABULAR ALUMINUM CADDY TRIAL LINER 40OD - 46OD28ID FDA UDI

Identifiers

Catalog Number: 480060028 FDA UDI
Primary DI / UDI-DI: 10603295524045 FDA UDI
FDA Product Code: LPH FDA UDI
LZO FDA UDI
GMDN Term: Instrument tray, reusable FDA UDI

Classification

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

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: Instrument tray, reusable

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

Similar devices

Also classified as Instrument tray, reusable.

MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
Instrument Case — Katena Products, Inc. · Class I
Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
SHEFFIELD RING FIXATOR — Orthofix, Inc. · Class II
MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
ASELTECH — Asel Tibbi Aletler A.S. · Class I

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Depuy (ireland)

Sources (1)

FDA UDI fb447b6e-8d8e-4635-9f92-f38c242c589a 35 fields · synced Jun 1, 2026