Profemur®

FDA UDI

Class II (US FDA UDI)

by MicroPort Orthopedics Inc.

Identity

Trade Name: PROFEMUR® FDA UDI
Generic Name: Femoral head/stem prosthesis adaptor FDA UDI
Device Name: "PROFEMUR® R" PROX BODY PLASMA SPRAY X-SMALL MODULAR FDA UDI
Model / Reference: PPW38354 FDA UDI
Description: "PROFEMUR® R" PROX BODY PLASMA SPRAY X-SMALL MODULAR FDA UDI

Identifiers

Catalog Number: PPW38354 FDA UDI
Primary DI / UDI-DI: M684PPW383541 FDA UDI
FDA Product Code: MAY FDA UDI
LWJ FDA UDI
LZO FDA UDI
GMDN Term: Femoral head/stem prosthesis adaptor FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 FDA UDI
888.3360 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: Femoral head/stem prosthesis adaptor

Profemur® by MicroPort Orthopedics 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: MicroPort Orthopedics Inc.

Sources (1)

FDA UDI ae1f7688-5c02-43c4-9d98-ba34c1fc7c69 35 fields · synced Jun 9, 2026