Durasul®

FDA UDI

Class II (US FDA UDI)

by Zimmer, Inc.

Identity

Trade Name: Durasul® FDA UDI
Generic Name: Non-constrained polyethylene acetabular liner FDA UDI
Model / Reference: 4376-38-069 FDA UDI

Identifiers

Catalog Number: 4376-38-069 FDA UDI
Primary DI / UDI-DI: 00889024168909 FDA UDI
510(k) Number: K993259 FDA UDI
FDA Product Code: JDI FDA UDI
LPH FDA UDI
GMDN Term: Non-constrained polyethylene acetabular liner FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3350 FDA UDI
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

Dimensions & Sizes

Size: Lumen/Inner Diameter — 38 Millimeter FDA UDI
Outer Diameter — 69 Millimeter FDA UDI

Category: Non-constrained polyethylene acetabular liner

Durasul® by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-constrained polyethylene acetabular liner.

C-Fit & DC-Fit Acetabular Cup System — CORIN LTD · Class II
RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
MobileLink Acetabular Cup System — WALDEMAR LINK GmbH & Co. KG · Class II
PRIME — MicroPort Orthopedics Inc. · Class II
G7 Acetabular Liner — Biomet Orthopedics, Inc. · Class II
Logical 20° Hooded Liner — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
RINGLOC RX90-2 HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
PINNACLE — DEPUY ORTHOPAEDICS, INC. · Class II

Cleared under the same submission

K993259 also covers:

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: Zimmer, Inc.

Sources (1)

FDA UDI e3362bef-75f0-4383-b6cf-feb55724e4d0 36 fields · synced May 30, 2026