| Primary Device ID | 07630003566529 |
| NIH Device Record Key | 533eca5a-6435-45f0-86ca-c617c7ca0a41 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | M320 TC12 |
| Version Model Number | 000000000010448537 |
| Company DUNS | 480198725 |
| Company Name | Leica Microsystems (Schweiz) 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Special Storage Condition, Specify | Between 0 and 0 * |
| Special Storage Condition, Specify | Between 0 and 0 * |
| Special Storage Condition, Specify | Between 0 and 0 * |
| Special Storage Condition, Specify | Between 0 and 0 * |
| Special Storage Condition, Specify | Between 0 and 0 * |
| Special Storage Condition, Specify | Between 0 and 0 * |
| Special Storage Condition, Specify | Between 0 and 0 * |
| Special Storage Condition, Specify | Between 0 and 0 * |
| Special Storage Condition, Specify | Between 0 and 0 * |
| Special Storage Condition, Specify | Between 0 and 0 * |
| Special Storage Condition, Specify | Between 0 and 0 * |
| Special Storage Condition, Specify | Between 0 and 0 * |
| Special Storage Condition, Specify | Between 0 and 0 * |
| Special Storage Condition, Specify | Between 0 and 0 * |
| Special Storage Condition, Specify | Between 0 and 0 * |
| Special Storage Condition, Specify | Between 0 and 0 * |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07630003566529 [Primary] |
| EPT | MICROSCOPE, SURGICAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-01 |
| Device Publish Date | 2021-06-23 |
| 07630003501612 - M320 Optics Carrier | 2024-09-09 M320 Optics Carrier incl. Swing arm - for Leica surgical operating microscope systems: M320 FP12, M320 F12, M320 TP12, M320 LW12 |
| 07630802402615 - GLOW800 | 2024-05-13 GLOW800 - Accessory for Leica surgical operating microscope systems |
| 07630802402622 - ARveo 8 | 2024-05-13 ARveo 8 stand system for M530 microscope - for Leica surgical operating microscope system: ARveo 8 |
| 07630802403810 - MyVeo | 2024-05-13 MyVeo - Complete device including the Connection Hub, all Connection Cables and one MyVeo Headset |
| 07630802403827 - MyVeo Headset | 2024-05-10 MyVeo Headset - additional Headset to MyVeo Connection Hub |
| 07630003567717 - RUV800 WD175 | 2022-08-29 RUV800 WD175 - Accessory for Leica surgical operating microscope systems |
| 07630003567724 - Leica RUV800 WD200 | 2022-08-29 RUV800 WD200 - Accessory for Leica surgical operating microscope systems |
| 07630003599008 - PROVEO 8 F42 | 2022-04-08 PROVEO 8 Stand F42, OCT Ready variant - for Leica surgical operating microscope system: PROVEO 8 |