Identity
- Trade Name
- bioli™ IOL Delivery System FDA UDI
- Generic Name
- Manual intraocular lens injector, single-use FDA UDI
- Device Name
- The bioli™ IOL Delivery System is a single-use, sterile device intended to insert an approved single-piece foldable acrylic intraocular lens (IOL) into the human eye through an incision. The bioli™ IOL Delivery System is only for the insertion of Lenstec Softec I IOL and IOL models validated for use with this device as indicated in the approved IOL labeling. FDA UDI
- Model / Reference
- BIOLI-A1 FDA UDI
- Description
- The bioli™ IOL Delivery System is a single-use, sterile device intended to insert an approved single-piece foldable acrylic intraocular lens (IOL) into the human eye through an incision. The bioli™ IOL Delivery System is only for the insertion of Lenstec Softec I IOL and IOL models validated for use with this device as indicated in the approved IOL labeling. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10814899027164 FDA UDI
- 510(k) Number
- K200057 FDA UDI
- FDA Product Code
- MSS FDA UDI
- GMDN Term
- Manual intraocular lens injector, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4300 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
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
Yes
FDA UDI
Category: Manual intraocular lens injector, single-use
bioli™ IOL Delivery System by Ast Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Ast Products, Inc.
Sources (1)
- FDA UDI ca2af87c-ade0-4b7e-b0a9-d8e5146d14ae 34 fields · synced May 30, 2026