Identity
- Trade Name
- Polaris™ EUDAMEDPolaris™ Ultra FDA UDI
- Generic Name
- Polymeric ureteral stent FDA UDI
- Device Name
- Polaris Ultra Side Holes Stent Set EUDAMEDUreteral Stent Set FDA UDI
- Model / Reference
- M006192142050 EUDAMEDFDA UDI
- Description
- Ureteral Stent Set FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08714729798989 EUDAMEDFDA UDI
- Basic UDI-DI
- 01915060000000000000064MS EUDAMED
- FDA Product Code
- FAD FDA UDI
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Polymeric ureteral stent FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4620 FDA UDI
- Medical Purpose
- Ureteral Stent Set EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA 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
Yes
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
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
Polaris™ by Boston Scientific Corporation — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 01915060000000000000064MS | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Boston Scientific Corporation
- EUDAMED SRN
- US-PR-000008885
Sources (2)
- EUDAMED 108d3478-13af-4bb9-b6bb-eb4b60039885 61 fields · synced Oct 7, 2026
- FDA UDI e1d86fb6-1b37-4022-b5c4-c1f25fb6e2ee 34 fields · synced May 30, 2026