Identity
- Trade Name
- Solyx™ Blue FDA UDI
- Generic Name
- Female stress urinary incontinence surgical mesh-sling, synthetic polymer FDA UDI
- Device Name
- SIS System FDA UDI
- Model / Reference
- M0068507010 FDA UDI
- Description
- SIS System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729961901 FDA UDI
- FDA Product Code
- PAH FDA UDI
- GMDN Term
- Female stress urinary incontinence surgical mesh-sling, synthetic polymer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Female stress urinary incontinence surgical mesh-sling, synthetic polymer
Solyx™ Blue by Boston Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Boston Scientific
Sources (1)
- FDA UDI 9d310a8f-d90a-4f13-9c71-08285af4f10b 33 fields · synced Jun 8, 2026