BICEL I/A curved / 23G terralution

GUDID 07630055244048

I/A handpiece

Medicel AG

Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

• Primary Device ID: 07630055244048
• NIH Device Record Key: 5e253b47-f512-495e-a959-1ef588889737
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BICEL I/A curved / 23G terralution
• Version Model Number: BIT23A
• Company DUNS: 487158263
• Company Name: Medicel AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630055244048 [Primary]

FDA Product Code

• HMX: Cannula, Ophthalmic

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: 2025-06-05
• Device Publish Date: 2025-05-28

Devices Manufactured by Medicel AG

• 07630055244031 - BICEL I/A curved / 21G terralution: 2025-06-05 I/A handpiece
• 07630055244048 - BICEL I/A curved / 23G terralution: 2025-06-05I/A handpiece
• 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.