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 - Glenosphere Locking Bolt STD-ECC FDA UDI
- Model / Reference
- RSA Glenosphere Locking Bolt STD-ECC FDA UDI
- Description
- Shoulder Innovations Inset Reverse Total Shoulder - Glenosphere Locking Bolt STD-ECC FDA UDI
Identifiers
- Catalog Number
- 2R1GB40720 FDA UDI
- Primary DI / UDI-DI
- B1132R1GB407200 FDA UDI
- FDA Product Code
- PHX FDA UDIMBF FDA UDI
- GMDN Term
- Total shoulder prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3670 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Radiation 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 034632f0-d1ac-417a-86df-4a221e98cb6c 36 fields · synced Jun 8, 2026