Procotyl® Prime

FDA UDI

Class II (US FDA UDI)

by MicroPort Orthopedics Inc.

Identity

Trade Name: PROCOTYL® PRIME FDA UDI
Generic Name: Non-constrained polyethylene acetabular liner FDA UDI
Model / Reference: P3LXLF32 FDA UDI

Identifiers

Catalog Number: P3LXLF32 FDA UDI
Primary DI / UDI-DI: M684P3LXLF321 FDA UDI
FDA Product Code: LZO FDA UDI
LPH FDA UDI
GMDN Term: Non-constrained polyethylene acetabular liner FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 32 Millimeter FDA UDI

Category: Non-constrained polyethylene acetabular liner

Procotyl® Prime by MicroPort Orthopedics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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PINNACLE — DEPUY ORTHOPAEDICS, INC. · Class II
Continuum® Trilogy® Allofit® Longevity® — Zimmer, Inc. · 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: MicroPort Orthopedics Inc.

Sources (1)

FDA UDI 8627e7e4-0612-47f8-9f2c-52cb2ab51f09 35 fields · synced Jun 9, 2026