Identity
- Trade Name
- StabilEyes FDA UDI
- Generic Name
- Capsular tension ring FDA UDI
- Device Name
- Capsular Tension Ring 12.0 mm. FDA UDI
- Model / Reference
- STBL12US FDA UDI
- Description
- Capsular Tension Ring 12.0 mm. FDA UDI
Identifiers
- Catalog Number
- STBL12US FDA UDI
- Primary DI / UDI-DI
- 08717819039375 FDA UDI
- PMA Number
- P030023 FDA UDI
- FDA Product Code
- MRJ FDA UDI
- GMDN Term
- Capsular tension ring FDA UDI
Classification
- Device Class
- Class III 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 12 Millimeter FDA UDI
StabilEyes by Ophtec B.V. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P030023 also covers:
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 III | Pending data |
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Manufacturer
- Manufacturer
- Ophtec B.V.
Sources (1)
- FDA UDI fe46d444-a5da-4416-85f6-d100636ba86c 39 fields · synced Jun 8, 2026