Prime

FDA UDI

Class II (US FDA UDI)

by MicroPort Orthopedics Inc.

Identity

Trade Name: PRIME FDA UDI
Generic Name: Metallic acetabulum prosthesis FDA UDI
Device Name: PRIME BIOFOAM MULTI-HOLE SHELL 48 MM GROUP B FDA UDI
Model / Reference: P3SBMB48 FDA UDI
Description: PRIME BIOFOAM MULTI-HOLE SHELL 48 MM GROUP B FDA UDI

Identifiers

Catalog Number: P3SBMB48 FDA UDI
Primary DI / UDI-DI: 00192629280458 FDA UDI
FDA Product Code: MBL FDA UDI
LZO FDA UDI
LPH FDA UDI
GMDN Term: Metallic acetabulum prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3358 FDA UDI
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

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Metallic acetabulum prosthesis

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

Similar devices

Also classified as Metallic acetabulum prosthesis.

TRABECULAR METAL™ — Zimmer Trabecular Metal Technology, Inc. · Class II
Platform Acetabular Cup with Ti-Coat — TOTAL JOINT ORTHOPEDICS, INC. · Class II
b-ONE™ Primary Acetabular System — b-ONE Ortho Corp. · Class II
Contour — Smith & Nephew, Inc. · Class II
REGENEREX HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
DELTA TT Pro — Limacorporate · Class II
Mpact 3D Metal — Medacta International · Class II
BENCOX Hip System — Corentec Co., Ltd · 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 c3d01d50-3830-48c1-ba43-d520c9ccbb98 35 fields · synced Jun 9, 2026