Identity
- Trade Name
- PERFORM™ HUMERAL SYSTEM FDA UDI
- Generic Name
- Polyethylene reverse shoulder prosthesis cup FDA UDI
- Model / Reference
- DWS4393 FDA UDI
Identifiers
- Catalog Number
- DWS4393 FDA UDI
- Primary DI / UDI-DI
- 00846832078271 FDA UDI
- FDA Product Code
- PAO FDA UDI
- GMDN Term
- Polyethylene reverse shoulder prosthesis cup FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 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
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 39 Millimeter FDA UDI
Category: Polyethylene reverse shoulder prosthesis cup
Perform™ Humeral System by Tornier, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyethylene reverse shoulder prosthesis cup.
- FX V135 Shoulder Prosthesis — FX SOLUTIONS · Class II
- Equinoxe® — Exactech, Inc. · Class II
- HUMERIS 135 — FX SOLUTIONS · Class II
- SMR System — Limacorporate · Class II
- LINK Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG · Class II
- Equinoxe — Exactech, Inc. · Class II
- Equinoxe® — Exactech, Inc. · Class II
- LINK Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG · 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
- Tornier, Inc.
Sources (1)
- FDA UDI c119466c-aa49-4393-8e9a-1b3ab737f2ee 35 fields · synced May 31, 2026