| Primary Device ID | D79010612043 |
| NIH Device Record Key | 22d4ed4d-f870-48bf-a675-73bcd32a04c4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SuperNova |
| Version Model Number | 1061204 |
| Catalog Number | 1061204 |
| Company DUNS | 828690904 |
| Company Name | PURELIFE, LLC |
| Device Count | 200 |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 877-777-3303 |
| sales@purelifedental.com | |
| Phone | 877-777-3303 |
| sales@purelifedental.com | |
| Phone | 877-777-3303 |
| sales@purelifedental.com | |
| Phone | 877-777-3303 |
| sales@purelifedental.com | |
| Phone | 877-777-3303 |
| sales@purelifedental.com | |
| Phone | 877-777-3303 |
| sales@purelifedental.com | |
| Phone | 877-777-3303 |
| sales@purelifedental.com | |
| Phone | 877-777-3303 |
| sales@purelifedental.com | |
| Phone | 877-777-3303 |
| sales@purelifedental.com | |
| Phone | 877-777-3303 |
| sales@purelifedental.com | |
| Phone | 877-777-3303 |
| sales@purelifedental.com | |
| Phone | 877-777-3303 |
| sales@purelifedental.com | |
| Phone | 877-777-3303 |
| sales@purelifedental.com | |
| Phone | 877-777-3303 |
| sales@purelifedental.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D79010612040 [Unit of Use] |
| HIBCC | D79010612041 [Primary] |
| HIBCC | D79010612043 [Package] Contains: D79010612041 Package: Case [2000 Units] In Commercial Distribution |
| LZA | Polymer Patient Examination Glove |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-01 |
| Device Publish Date | 2020-08-24 |
| D79010612053 | SuperNova Nitrile Powder-Free, X-Large, Revolutionary stretchy nitrile provides superior comfort |
| D79010612043 | SuperNova Nitrile Powder-Free, Large, Revolutionary stretchy nitrile provides superior comfort a |
| D79010612033 | SuperNova Nitrile Powder-Free, Medium, Revolutionary stretchy nitrile provides superior comfort |
| D79010612023 | SuperNova Nitrile Powder-Free, Small, Revolutionary stretchy nitrile provides superior comfort a |
| D79010612013 | SuperNova Nitrile Powder-Free, X-Small, Revolutionary stretchy nitrile provides superior comfort |