| Primary Device ID | 00810038090443 |
| NIH Device Record Key | 7a1e3e94-71b0-46f6-bed8-d9426b92844d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fusion |
| Version Model Number | DME-02 |
| Catalog Number | DME-02 |
| Company DUNS | 057647005 |
| Company Name | GARRISON DENTAL SOLUTIONS, L.L.C. |
| 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 | true |
| Single Use | true |
| Lot Batch | true |
| 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 |
| Phone | 8884370032 |
| mmorris@garrisondental.com | |
| Phone | 8884370032 |
| mmorris@garrisondental.com | |
| Phone | 8884370032 |
| mmorris@garrisondental.com | |
| Phone | 8884370032 |
| mmorris@garrisondental.com | |
| Phone | 8884370032 |
| mmorris@garrisondental.com | |
| Phone | 8884370032 |
| mmorris@garrisondental.com | |
| Phone | 8884370032 |
| mmorris@garrisondental.com | |
| Phone | 8884370032 |
| mmorris@garrisondental.com | |
| Phone | 8884370032 |
| mmorris@garrisondental.com | |
| Phone | 8884370032 |
| mmorris@garrisondental.com | |
| Phone | 8884370032 |
| mmorris@garrisondental.com | |
| Phone | 8884370032 |
| mmorris@garrisondental.com | |
| Phone | 8884370032 |
| mmorris@garrisondental.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810038090443 [Primary] |
| JEP | Retainer, Matrix |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810038090443]
Moist Heat or Steam Sterilization
[00810038090443]
Moist Heat or Steam Sterilization
[00810038090443]
Moist Heat or Steam Sterilization
[00810038090443]
Moist Heat or Steam Sterilization
[00810038090443]
Moist Heat or Steam Sterilization
[00810038090443]
Moist Heat or Steam Sterilization
[00810038090443]
Moist Heat or Steam Sterilization
[00810038090443]
Moist Heat or Steam Sterilization
[00810038090443]
Moist Heat or Steam Sterilization
[00810038090443]
Moist Heat or Steam Sterilization
[00810038090443]
Moist Heat or Steam Sterilization
[00810038090443]
Moist Heat or Steam Sterilization
[00810038090443]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-29 |
| Device Publish Date | 2022-08-19 |
| 00810038090443 | Deep Margin Elevation Kit |
| 00810038090436 | Deep Margin Elevation Kit |