Identity
- Trade Name
- REUNION FDA UDI
- Generic Name
- Metallic reverse shoulder prosthesis cup FDA UDI
- Device Name
- Humeral Cup FDA UDI
- Model / Reference
- 5570-4002 FDA UDI
- Description
- Humeral Cup FDA UDI
Identifiers
- Catalog Number
- 5570-4002 FDA UDI
- Primary DI / UDI-DI
- 07613327516265 FDA UDI
- FDA Product Code
- PHX FDA UDIKWS FDA UDI
- GMDN Term
- Metallic 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Metallic reverse shoulder prosthesis cup
Reunion by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metallic reverse shoulder prosthesis cup.
- Arthrex® — Arthrex, Inc. · Class II
- Anatomical Shoulder™ — Zimmer, Inc. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- SMR System — Limacorporate · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- PRIMA — Limacorporate · 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
- Stryker Corp.
Sources (1)
- FDA UDI 184b51b5-1f29-44b0-b3d0-78ec5a3c4473 35 fields · synced Jun 6, 2026