PE insert 0° 4mm offset

FDA UDI

Class II (US FDA UDI)

by implantcast GmbH

Identity

Trade Name: PE insert 0° 4mm offset FDA UDI
Generic Name: Non-constrained polyethylene acetabular liner FDA UDI
Model / Reference: 02813239 FDA UDI

Identifiers

Primary DI / UDI-DI: 04048844328207 FDA UDI
FDA Product Code: LZO FDA UDI
OQI FDA UDI
GMDN Term: Non-constrained polyethylene acetabular liner FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

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

Category: Non-constrained polyethylene acetabular liner

PE insert 0° 4mm offset by implantcast GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Logical 20° Hooded Liner — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
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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: implantcast GmbH

Sources (1)

FDA UDI 4fcce526-1ca1-4853-a146-8c3e11a24528 33 fields · synced May 31, 2026