| Primary Device ID | 10886874119591 |
| NIH Device Record Key | 1575231b-193a-4d95-b5f5-5bc5840d1381 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ion |
| Version Model Number | 490127 |
| Company DUNS | 938647021 |
| Company Name | INTUITIVE SURGICAL, INC. |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00886874119594 [Primary] |
| GS1 | 10886874119591 [Package] Contains: 00886874119594 Package: BOX [10 Units] In Commercial Distribution |
| GS1 | 30886874119595 [Package] Package: CASE [6 Units] In Commercial Distribution |
| PUI | Drape, surgical, exempt |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-11 |
| Device Publish Date | 2020-09-03 |
| 00886874116241 | Controller |
| 00886874116234 | System Cart |
| 10886874116125 | Vision Probe |
| 00886874116258 | Catheter |
| 10886874119591 | None |
| 00886874121184 | Vision Probe |
| 00886874124796 | Catheter |