Prima

FDA UDI

Class II (US FDA UDI)

by Limacorporate

Identity

Trade Name: PRIMA FDA UDI
Generic Name: Press-fit shoulder humeral stem prosthesis FDA UDI
Device Name: PRIMA - Short Stem Plus #6 (+30 mm) FDA UDI
Model / Reference: 1357.14.338 FDA UDI
Description: PRIMA - Short Stem Plus #6 (+30 mm) FDA UDI

Identifiers

Catalog Number: 1357.14.338 FDA UDI
Primary DI / UDI-DI: 08033390268660 FDA UDI
FDA Product Code: PHX FDA UDI
MBF FDA UDI
HSD FDA UDI
KWS FDA UDI
KWT FDA UDI
PAO FDA UDI
GMDN Term: Press-fit shoulder humeral stem prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3660 FDA UDI
888.3670 FDA UDI
888.3690 FDA UDI
888.3650 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: Press-fit shoulder humeral stem prosthesis

Prima by Limacorporate — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Press-fit shoulder humeral stem prosthesis.

Shoulder Innovations Humeral Stemless System — SHOULDER INNOVATIONS, Inc · Class II
GLOBAL AP — DEPUY ORTHOPAEDICS, INC. · Class II
GLOBAL ADVANTAGE — DEPUY ORTHOPAEDICS, INC. · Class II
GLOBAL AP — DEPUY ORTHOPAEDICS, INC. · Class II
BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc. · Class II
GLOBAL AP — DEPUY ORTHOPAEDICS, INC. · Class II
Equinoxe — Exactech, Inc. · Class II
Shoulder Innovations InSet Humeral Stemless — SHOULDER INNOVATIONS, 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: Limacorporate

Sources (1)

FDA UDI 4599db62-548f-42a3-b93b-ce35890ca7aa 35 fields · synced May 30, 2026