Actis

FDA UDI

Class II (US FDA UDI)

by Depuy (ireland)

Identity

Trade Name: ACTIS FDA UDI
Generic Name: Orthopaedic broach FDA UDI
Device Name: ACTIS HIP SYSTEM BROACH SIZE 3 FDA UDI
Model / Reference: 3010-01-030 FDA UDI
Description: ACTIS HIP SYSTEM BROACH SIZE 3 FDA UDI

Identifiers

Catalog Number: 301001030 FDA UDI
Primary DI / UDI-DI: 10603295548621 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

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

Similar devices

Also classified as Orthopaedic broach.

EcoFit® broach for short stem 133° — implantcast GmbH · Class I
PyroCarbon PIP Total Joint System — Smith & Nephew, Inc. · Class I
INSTRUMENT — Howmedica Osteonics Corp. · Class I
Equinoxe — Exactech, Inc. · Class II
Anthology — Smith & Nephew, Inc. · Class I
Affinity J (Instruments for Microscope) — MEDTRONIC SOFAMOR DANEK, INC. · Class I
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 ea45c9c4-4e06-4d52-bfb6-cc4823e8ca44 35 fields · synced May 30, 2026