| Primary Device ID | 08806383556699 |
| NIH Device Record Key | 2958a29c-38d3-4b3a-a786-ddd7da3b6003 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DUO-GUN |
| Version Model Number | DUO-GUN GP Obturation Tip(25G, 1ea) |
| Catalog Number | 4007-2127 |
| Company DUNS | 687789453 |
| Company Name | DiaDent Group International |
| Device Count | 1 |
| 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 | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08806383556699 [Primary] |
| EKR | Plugger, Root Canal, Endodontic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08806383556699]
Moist Heat or Steam Sterilization
[08806383556699]
Moist Heat or Steam Sterilization
[08806383556699]
Moist Heat or Steam Sterilization
[08806383556699]
Moist Heat or Steam Sterilization
[08806383556699]
Moist Heat or Steam Sterilization
[08806383556699]
Moist Heat or Steam Sterilization
[08806383556699]
Moist Heat or Steam Sterilization
[08806383556699]
Moist Heat or Steam Sterilization
[08806383556699]
Moist Heat or Steam Sterilization
[08806383556699]
Moist Heat or Steam Sterilization
[08806383556699]
Moist Heat or Steam Sterilization
[08806383556699]
Moist Heat or Steam Sterilization
[08806383556699]
Moist Heat or Steam Sterilization
[08806383556699]
Moist Heat or Steam Sterilization
[08806383556699]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-06-03 |
| Device Publish Date | 2020-05-26 |
| 08806383557269 | Duo-Gun is an endodontic device that heat-soften specially-formulated Gutta Percha and enable ve |
| 08806383557252 | Duo-Gun is an endodontic device that heat-soften specially-formulated Gutta Percha and enable ve |
| 08806383557245 | Duo-Gun is an endodontic device that heat-soften specially-formulated Gutta Percha and enable ve |
| 08806383557238 | Duo-Gun is an endodontic device that heat-soften specially-formulated Gutta Percha and enable ve |
| 08806383557221 | Duo-Gun is an endodontic device that heat-soften specially-formulated Gutta Percha and enable ve |
| 08806383557092 | Duo-Gun is an endodontic device that heat-soften specially-formulated Gutta Percha and enable ve |
| 08806383556699 | Duo-Gun is an endodontic device that heat-soften specially-formulated Gutta Percha and enable ve |
| 08806383556682 | Duo-Gun is an endodontic device that heat-soften specially-formulated Gutta Percha and enable ve |
| 08806383586313 | Duo-Gun is an endodontic device that heat-soften specially-formulated Gutta Percha and enable ve |