| Primary Device ID | 00854137001641 |
| NIH Device Record Key | ffd92c3d-61a0-4dc7-b044-b977cb1cffa0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | eXofin Precision Pen High Viscosity Topical Skin Adhesive |
| Version Model Number | EP70412 |
| Company DUNS | 079163089 |
| Company Name | CHEMENCE MEDICAL PRODUCTS, 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00854137001634 [Primary] |
| GS1 | 00854137001641 [Package] Contains: 00854137001634 Package: Inner [12 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 | 2021-11-18 |
| Device Publish Date | 2021-11-10 |
| 00854137001665 - LiquidSkin, 1.0g | 2022-07-05 |
| 00854137001689 - exofin Mastic, 2 oz. | 2022-07-05 Class 1 |
| 00854137001696 - exofin Mastic, 0.67ml | 2022-07-05 Class 1 |
| 00854137001702 - exofin Mastic, 1 oz. | 2022-07-05 Class 1 |
| 00854137001719 - GluGone Adhesive Remover, 2 oz. | 2022-07-05 Glugone 2 oz |
| 00854137001726 - GluGone Adhesive Remover, 4 oz. | 2022-07-05 4 OZ |
| 10854137001730 - GluGone Adhesive Remover, 0.67 oz. | 2022-07-05 0.67 OZ |
| 00854137001740 - LiquidSkin, 0.5g | 2022-07-05 |