OMNI Interface Acetabular System

FDA UDI

Class II (US FDA UDI)

by OMNIlife science, Inc.

Identity

Trade Name: OMNI Interface Acetabular System FDA UDI
Generic Name: Acetabular shell FDA UDI
Device Name: Acetabular Shell, 58mm, 3 hole, flared, D Insert FDA UDI
Model / Reference: 410358 FDA UDI
Description: Acetabular Shell, 58mm, 3 hole, flared, D Insert FDA UDI

Identifiers

Catalog Number: 410358 FDA UDI
Primary DI / UDI-DI: 00841690100461 FDA UDI
FDA Product Code: LPH FDA UDI
GMDN Term: Acetabular shell FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

Sterilization Method

Ethylene Oxide FDA UDI

Category: Acetabular shell

OMNI Interface Acetabular System by OMNIlife science, Inc. — 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: OMNIlife science, Inc.

Sources (1)

FDA UDI e92c6858-4884-4878-b489-823447e694b2 35 fields · synced Jun 9, 2026