CART45S

GUDID 00844369018975

Box of 10 1.6mm CART45S injector cartridges

Lenstec Barbados Inc

Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge Intraocular lens-insertion cartridge

• Primary Device ID: 00844369018975
• NIH Device Record Key: e17e59a6-a6f3-48d8-97fe-8ba8fc0abab4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CART45S
• Version Model Number: CART45S
• Company DUNS: 860235001
• Company Name: Lenstec Barbados Inc
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-866-536-7832
• Email: feedback@lenstec.com
• Phone: 1-866-536-7832
• Email: feedback@lenstec.com
• Phone: 1-866-536-7832
• Email: feedback@lenstec.com
• Phone: 1-866-536-7832
• Email: feedback@lenstec.com
• Phone: 1-866-536-7832
• Email: feedback@lenstec.com
• Phone: 1-866-536-7832
• Email: feedback@lenstec.com
• Phone: 1-866-536-7832
• Email: feedback@lenstec.com
• Phone: 1-866-536-7832
• Email: feedback@lenstec.com
• Phone: 1-866-536-7832
• Email: feedback@lenstec.com
• Phone: 1-866-536-7832
• Email: feedback@lenstec.com
• Phone: 1-866-536-7832
• Email: feedback@lenstec.com
• Phone: 1-866-536-7832
• Email: feedback@lenstec.com
• Phone: 1-866-536-7832
• Email: feedback@lenstec.com
• Phone: 1-866-536-7832
• Email: feedback@lenstec.com
• Phone: 1-866-536-7832
• Email: feedback@lenstec.com
• Phone: 1-866-536-7832
• Email: feedback@lenstec.com
• Phone: 1-866-536-7832
• Email: feedback@lenstec.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844369018975 [Primary]
GS1	10844369018972 [Unit of Use]

FDA Product Code

• MSS: Folders And Injectors, Intraocular Lens (Iol)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-14
• Device Publish Date: 2024-05-06

Devices Manufactured by Lenstec Barbados Inc

• 00844369016858 - I9011S: 2024-05-14 Push Injector, titanium
• 00844369016865 - I9012: 2024-05-14 Threaded Injector, Course Thread, Large Knob, Titanium
• 00844369016872 - I9012FS: 2024-05-14 Threaded (Slow) Injector, Fine Thread, Small Knob, Titanium
• 00844369018944 - LC16: 2024-05-14 Box of 10 1.6mm LC16 injector cartridges
• 00844369018968 - LC24: 2024-05-14 Box of 10 2.4mm LC24 injector cartridges
• 00844369018975 - CART45S: 2024-05-14Box of 10 1.6mm CART45S injector cartridges
• 00844369018975 - CART45S: 2024-05-14 Box of 10 1.6mm CART45S injector cartridges
• 00844369018982 - CARTM: 2024-05-14 Box of 10 1.6mm CARTM injector cartridges
• 00844369002172 - SOFTEC HD PLI: 2018-07-06 IOL - HEMA 6.0/13mm (Pre-loaded)