VISCOJECT 1.8 Injector set LP604350

GUDID 07630055211941

Injectors and cartridges for the injection of intraocular lenses (IOL) into the eye during surgical procedures.

Medicel AG

Manual intraocular lens injector, single-use

• Primary Device ID: 07630055211941
• NIH Device Record Key: b7d6d2b3-cde0-42c5-ba32-4f31175358f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISCOJECT 1.8 Injector set
• Version Model Number: LP604350
• Catalog Number: LP604350
• Company DUNS: 487158263
• Company Name: Medicel AG
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com
• Phone: +41717271050
• Email: info@medicel.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630055211941 [Unit of Use]
GS1	07630055220080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101134

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: 2020-10-29
• Device Publish Date: 2020-10-21

Devices Manufactured by Medicel AG

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• 07630055244048 - BICEL I/A curved / 23G terralution: 2025-06-05 I/A handpiece
• 07630055241863 - I/A Coaxial Handpiece Set Sophi - 20G/65°: 2024-12-06 The Irrigation-/Aspiration-Handpieces are used to remove the opaque human lens during cataract surgery.
• 07630055241870 - I/A Coaxial Handpiece Set Sophi - 21G/45°: 2024-12-06 The Irrigation-/Aspiration-Handpieces are used to remove the opaque human lens during cataract surgery.
• 07630055241887 - I/A Coaxial Handpiece Set Sophi - 23G/45°: 2024-12-06 The Irrigation-/Aspiration-Handpieces are used to remove the opaque human lens during cataract surgery.
• 07630055241894 - I/A Coaxial Handpiece Set Sophi - 21G/45° Soft-Tip: 2024-12-06 The Irrigation-/Aspiration-Handpieces are used to remove the opaque human lens during cataract surgery.
• 07630055243287 - I/A Bimanual Handpiece Set Sophi -21G/Aeroplane: 2024-12-06 The Irrigation-/Aspiration-Handpieces are used to remove the opaque human lens during cataract surgery.
• 07630055243959 - I/A Coaxial Handpiece Set Sophi - 20G/45°: 2024-12-06 The Irrigation-/Aspiration-Handpieces are used to remove the opaque human lens during cataract surgery.