| Primary Device ID | 10817984010362 |
| NIH Device Record Key | 41f2e01c-2ad7-4362-be6a-b662d6179fcb |
| Commercial Distribution Discontinuation | 2020-01-10 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Laser Lavage |
| Version Model Number | 0600-3021-010 |
| Catalog Number | 0600-3021-000 |
| Company DUNS | 606939072 |
| Company Name | MECTRA LABS, 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)323-3968 |
| mectrasales@mectralas.com |
| Handling Environment Temperature | Between 20 Degrees Fahrenheit and 115 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817984010365 [Primary] |
| GS1 | 10817984010362 [Package] Contains: 00817984010365 Package: Inner [10 Units] Discontinued: 2020-01-10 Not in Commercial Distribution |
| GBX | CATHETER, IRRIGATION |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-01-13 |
| Device Publish Date | 2019-01-31 |
| 10817984010072 | Laser Lavage Double Bottle |
| 10817984010065 | Laser Lavage Dual Spike |
| 10817984010058 | Laser Lavage Single Spike |
| 10817984010362 | Laser Lavage 32CM Single Spike |