| Primary Device ID | D79011132010 |
| NIH Device Record Key | 8f5c3076-cbd8-475b-9207-8edc5423aa34 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PureLife+ Cotton Tip Applicators |
| Version Model Number | 1113201 |
| Catalog Number | 1113201 |
| Company DUNS | 828690904 |
| Company Name | PURELIFE, LLC |
| Device Count | 1000 |
| 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 | 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 | false |
| Phone | +1(877)777-3303 |
| sales@purelifedental.com | |
| Phone | +1(877)777-3303 |
| sales@purelifedental.com | |
| Phone | +1(877)777-3303 |
| sales@purelifedental.com | |
| Phone | +1(877)777-3303 |
| sales@purelifedental.com | |
| Phone | +1(877)777-3303 |
| sales@purelifedental.com | |
| Phone | +1(877)777-3303 |
| sales@purelifedental.com | |
| Phone | +1(877)777-3303 |
| sales@purelifedental.com | |
| Phone | +1(877)777-3303 |
| sales@purelifedental.com | |
| Phone | +1(877)777-3303 |
| sales@purelifedental.com | |
| Phone | +1(877)777-3303 |
| sales@purelifedental.com | |
| Phone | +1(877)777-3303 |
| sales@purelifedental.com | |
| Phone | +1(877)777-3303 |
| sales@purelifedental.com | |
| Phone | +1(877)777-3303 |
| sales@purelifedental.com | |
| Phone | +1(877)777-3303 |
| sales@purelifedental.com | |
| Phone | +1(877)777-3303 |
| sales@purelifedental.com | |
| Phone | +1(877)777-3303 |
| sales@purelifedental.com | |
| Phone | +1(877)777-3303 |
| sales@purelifedental.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D79011132010 [Unit of Use] |
| HIBCC | D79011132011 [Primary] |
| NAB | Gauze / sponge,nonresorbable for external use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-16 |
| Device Publish Date | 2023-06-08 |
| D79011132020 | PureLife+ Cotton Tip Applicators, 6", Non-sterile cotton tip applicators, Available in 3" or 6" |
| D79011132010 | PureLife+ Cotton Tip Applicators, 3", Non-sterile cotton tip applicators, Available in 3" or 6" |