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AST Products, Inc.

Matched from indexed company URL: AST PRODUCTS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10006353091000635309AST Products, Inc.1N2026-01-019 LINNELL CIR Billerica MA US 01821

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1777881104547536K200057bioli lOL Delivery SystemMSS2020-06-04
1777881704809983K182965BL-Cart IOL Delivery CartridgeMSS2019-03-29
1777881845294313K172228pioli IOL Delivery SystemMSS2017-12-15
1777881681097296K142056LIOLI IOL DELIVERY SYSTEMMSS2015-04-09

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MSS42020-06-04

PMN#

GUDID#

BL-Cart™ IOL Delivery Cartridge - 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.

AST PRODUCTS, INC.

2019-10-04