| Primary Device ID | D81375000 |
| NIH Device Record Key | e6396b4b-4eb1-4e63-abc1-783a9276291f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dry-Bond |
| Version Model Number | 7500 |
| Catalog Number | 7500 |
| Company DUNS | 809857704 |
| Company Name | DEN-MAT HOLDINGS, LLC |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-800-433-6628 |
| info@denmat.com | |
| Phone | 1-800-433-6628 |
| info@denmat.com |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to source of ignition or open flame |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to source of ignition or open flame |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to source of ignition or open flame |
| Handling Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Do not expose to source of ignition or open flame |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D81375000 [Primary] |
| KZP | Solution, Cement Disolving |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
| D81375500 | DRY-BOND 25mL |
| D81375250 | COMP SOLVENT/SURFACE COND 25mL |
| D81375000 | DRY-BOND 240mL |
| D8130307550000 | DRY-BOND 10mL W/INST |