Identity
- Trade Name
- Shoulder Innovations Inset Reverse Total Shoulder FDA UDI
- Generic Name
- Total shoulder prosthesis FDA UDI
- Device Name
- Shoulder Innovations Inset Reverse Total Shoulder - RSA 0° Angled Reamer Sleeve FDA UDI
- Model / Reference
- RSA 0° Angled Reamer Sleeve FDA UDI
- Description
- Shoulder Innovations Inset Reverse Total Shoulder - RSA 0° Angled Reamer Sleeve FDA UDI
Identifiers
- Catalog Number
- 2R2GA10000 FDA UDI
- Primary DI / UDI-DI
- B1132R2GA100000 FDA UDI
- FDA Product Code
- MBF FDA UDIPHX FDA UDI
- GMDN Term
- Total shoulder prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3670 FDA UDI888.3660 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Moist Heat or Steam Sterilization FDA UDI
Shoulder Innovations Inset Reverse Total Shoulder by SHOULDER INNOVATIONS, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- SHOULDER INNOVATIONS, Inc
Sources (1)
- FDA UDI b40c3bd4-d043-4012-98b7-6833760d1657 36 fields · synced May 30, 2026