| Primary Device ID | 00810032660734 |
| NIH Device Record Key | 6edc8c97-ebae-4591-87a4-7bb09df602b3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Isolite, i2 |
| Version Model Number | PIL0207 |
| Catalog Number | PIL0207 |
| Company DUNS | 068038277 |
| Company Name | ZYRIS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | true |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810032660734 [Primary] |
| EAZ | LIGHT, OPERATING, DENTAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-29 |
| Device Publish Date | 2024-04-19 |
| 00810032660758 | Isolite 2 ; Isodry Anterior Adapter Kit |
| 00810032660734 | Power Adaptor, 5VDC-1Amp, Grey |
| 00810032660710 | Vacuum Lever Set |
| 00810032660703 | Vacuum Light Pipe |