| Primary Device ID | 10860000589038 |
| NIH Device Record Key | ae27e61c-c7f6-4530-82d0-ffb4c209a147 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tissue Seal |
| Version Model Number | 1051260-P |
| Company DUNS | 805666588 |
| Company Name | TISSUE SEAL L.L.C. |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | 877-754-6458 |
| info@tissueseal.com |
| Total Volume | 0.5 Milliliter |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860000589031 [Primary] |
| GS1 | 10860000589038 [Package] Contains: 00860000589031 Package: Box [10 Units] In Commercial Distribution |
| MPN | Tissue Adhesive For The Topical Approximation Of Skin |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-12-09 |
| Device Publish Date | 2019-12-01 |
| 10860000589038 | Topical Skin Adhesive Flex with Tips |
| 10860000589021 | Topical Skin Adhesive Clear |
| 00860000589000 | Topical Skin Adhesive Blue |