| Primary Device ID | 00000000000000 |
| NIH Device Record Key | 397dfbf4-0689-4d89-bd12-c0ca2b6739ab |
| Commercial Distribution Discontinuation | 2023-11-30 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Coaxial I/A 4521ST |
| Version Model Number | MCS4521ST |
| Catalog Number | MCS4521ST |
| Company DUNS | 487158263 |
| Company Name | Medicel AG |
| Device Count | 10 |
| 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 | 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 |
| Phone | +41717271050 |
| info@medicel.com | |
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| Phone | +1(423)598-2680 |
| jahmal.cannon@zeiss.com | |
| Phone | +1(423)598-2680 |
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| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00000000000000 [Unit of Use] |
| GS1 | 04064495039415 [Primary] |
| GS1 | 07630055253378 [Primary] |
| GS1 | 07640123272101 [Primary] |
| GS1 | 07640123277724 [Primary] |
| GS1 | 07640123277731 [Primary] |
| GS1 | 07640123277748 [Primary] |
| GS1 | 07640123277755 [Primary] |
| GS1 | 07640123277779 [Primary] |
| GS1 | 07640123277786 [Primary] |
| EYJ | Holder, Ureteral Catheter |
| HMX | Cannula, Ophthalmic |
| HQG | Lens, spectacle, non-custom (prescription) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-12-04 |
| Device Publish Date | 2021-09-08 |
| 07630055242594 | The Irrigation-/Aspiration Handpieces are used to remove the opaque human lens during cataract s |
| 00000000000000 | The Irrigation-/Aspiration Handpieces are used to remove the opaque human lens during cataract s |