| Primary Device ID | 10816982020076 |
| NIH Device Record Key | a3ba586c-382f-4ae2-806a-9b07a238b5ef |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | TVS-P0063ORB |
| Company DUNS | 809254670 |
| Company Name | COASTAL LIFE TECHNOLOGIES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816982020079 [Primary] |
| GS1 | 10816982020076 [Package] Contains: 00816982020079 Package: [5 Units] In Commercial Distribution |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-23 |
| 10814716020224 - Surgimedics® | 2024-05-03 Smoke Evacuation Tubing |
| 10814716020231 - Surgimedics® | 2024-05-03 Smoke Evacuation Tubing |
| 10814716020262 - Surgimedics® | 2024-05-03 Smoke Evacuation Tubing Adapter |
| 10814716020279 - Surgimedics® | 2024-05-03 Smoke Evacuation Tubing Adapter |
| 10814716020729 - Surgimedics® | 2024-05-03 Smoke Evacuation Tubing Adapter |
| 10814716020736 - Surgimedics® | 2024-05-03 Smoke Evacuation Tubing Adapter |
| 10814716020743 - Surgimedics® | 2024-05-03 Smoke Evacuation Tubing Adapter |
| 10814716020750 - Surgimedics® | 2024-05-03 Smoke Evacuation Tubing Adapter |