Identity
- Trade Name
- Eye-Cept Sterile Saline Solution FDA UDI
- Generic Name
- Contact lens rinsing solution FDA UDI
- Device Name
- 10ml single use sterile saline solution for soft contact lens FDA UDI
- Model / Reference
- 431 FDA UDI
- Description
- 10ml single use sterile saline solution for soft contact lens FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00364108431242 FDA UDI
- 510(k) Number
- K110221 FDA UDI
- FDA Product Code
- LPN FDA UDI
- GMDN Term
- Contact lens rinsing solution FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.5928 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Category: Contact lens rinsing solution
Eye-Cept Sterile Saline Solution by Optics Laboratory, Inc. — 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
- Optics Laboratory, Inc.
Sources (1)
- FDA UDI 05458f7e-9912-442d-b8f8-2a6c17517363 34 fields · synced Jun 1, 2026