Identity
- Trade Name
- BL-Cart™ IOL Delivery Cartridge FDA UDI
- Generic Name
- Intraocular lens-insertion cartridge FDA UDI
- Device Name
- The BL-Cart™ IOL Delivery Cartridge is a single-use, sterile device intended to insert an approved single-piece foldable acrylic intraocular lens (IOL) into the human eye through a surgical procedure. The cartridge is intended to be used in conjunction with Alcon Monarch® III IOL Delivery System injector. The BL-Cart™ IOL Delivery Cartridge 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
- Type D FDA UDI
- Description
- The BL-Cart™ IOL Delivery Cartridge is a single-use, sterile device intended to insert an approved single-piece foldable acrylic intraocular lens (IOL) into the human eye through a surgical procedure. The cartridge is intended to be used in conjunction with Alcon Monarch® III IOL Delivery System injector. The BL-Cart™ IOL Delivery Cartridge 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
- 10814899027065 FDA UDI
- 510(k) Number
- K182965 FDA UDI
- FDA Product Code
- MSS FDA UDI
- GMDN Term
- Intraocular lens-insertion cartridge 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: Intraocular lens-insertion cartridge
BL-Cart™ IOL Delivery Cartridge by Ast Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intraocular lens-insertion cartridge.
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- SMARTLOAD — Johnson & Johnson Surgical Vision, Inc. · Class III
- SMARTLOAD — Johnson & Johnson Surgical Vision, Inc. · Class III
- SMARTLOAD — Johnson & Johnson Surgical Vision, Inc. · Class III
- SMARTLOAD — Johnson & Johnson Surgical Vision, Inc. · Class III
- SMARTLOAD — Johnson & Johnson Surgical Vision, Inc. · Class III
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 16a66f9f-c534-4d7a-9a89-6600ae8486fb 34 fields · synced May 30, 2026