| Primary Device ID | 07630055241870 | 
| NIH Device Record Key | 1e434a83-4bea-4040-a4f4-33fdbe573a4e | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | I/A Coaxial Handpiece Set Sophi - 21G/45° | 
| Version Model Number | 1401-2221 | 
| Catalog Number | 1401-2221 | 
| 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 | 
| Phone | +41717271050 | 
| info@medicel.com | |
| Phone | +41717271050 | 
| info@medicel.com | |
| Phone | +41717271050 | 
| info@medicel.com | |
| Phone | +41717271050 | 
| info@medicel.com | |
| Phone | +41717271050 | 
| info@medicel.com | |
| Phone | +41717271050 | 
| info@medicel.com | |
| Phone | +41717271050 | 
| info@medicel.com | |
| Phone | +41717271050 | 
| info@medicel.com | |
| Phone | +41717271050 | 
| info@medicel.com | |
| Phone | +41717271050 | 
| info@medicel.com | |
| Phone | +41717271050 | 
| info@medicel.com | |
| Phone | +41717271050 | 
| info@medicel.com | |
| Phone | +41717271050 | 
| info@medicel.com | |
| Phone | +41717271050 | 
| info@medicel.com | |
| Phone | +41717271050 | 
| info@medicel.com | |
| Phone | +41717271050 | 
| info@medicel.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 07630055241870 [Primary] | 
| HMX | Cannula, Ophthalmic | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2024-12-06 | 
| Device Publish Date | 2024-11-28 | 
| 07630055244031 - BICEL I/A curved / 21G terralution | 2025-06-05 I/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° | 2024-12-06The 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. |