| Primary Device ID | 10854137001624 |
| NIH Device Record Key | 9aaa1325-5f2d-4d82-b359-c31a46602c65 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | eXofin High Viscosity Topical Skin Adhesive |
| Version Model Number | EX70410 |
| 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 | 00854137001627 [Primary] |
| GS1 | 10854137001624 [Package] Contains: 00854137001627 Package: Inner Case [10 Units] In Commercial Distribution |
| GS1 | 30854137001628 [Package] Contains: 00854137001627 Package: Box [10 Units] In Commercial Distribution |
| GS1 | 40854137001625 [Package] Contains: 30854137001628 Package: Case [6 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 | 2021-11-08 |
| Device Publish Date | 2021-10-29 |
| 20854137001621 | High Viscosity Topical Skin Adhesive |
| 10854137001624 | Cyanoacrylate based topical skin adhesive |