Identity
- Trade Name
- U.S. IOL, Inc. FDA UDI
- Generic Name
- Ophthalmic surgical dye FDA UDI
- Device Name
- U-BLUE Trypan Blue Solution 0.06% FDA UDI
- Model / Reference
- U-BLUE FDA UDI
- Description
- U-BLUE Trypan Blue Solution 0.06% FDA UDI
Identifiers
- Catalog Number
- U-BLUE FDA UDI
- Primary DI / UDI-DI
- 00803878044721 FDA UDI
- 510(k) Number
- K024090 FDA UDI
- FDA Product Code
- GAR FDA UDI
- GMDN Term
- Ophthalmic surgical dye FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5020 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
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
Moist Heat or Steam Sterilization FDA UDI
Category: Ophthalmic surgical dye
U.S. IOL, Inc. by U.S. Iol, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- U.S. Iol, Inc.
Sources (1)
- FDA UDI 1d9da62a-77b2-4835-a0a3-618c149014c2 37 fields · synced May 30, 2026