| Primary Device ID | 00083208025648 |
| NIH Device Record Key | 830d960b-1b3b-4cfc-a170-39b1f99875cd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ITL Dental |
| Version Model Number | HTRAL latch grip .050 driver |
| Catalog Number | HTRAL latch grip .050 driver |
| Company DUNS | 078352849 |
| Company Name | Suncoast Dental, Inc |
| 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 | 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 | 1-727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 1-727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 1-727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 1-727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 1-727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 1-727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 1-727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 1-727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 1-727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 1-727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 1-727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 1-727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 1-727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 1-727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 1-727-536-4880 |
| tatumcompliance@gmail.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00083208025648 [Primary] |
| DZN | Instruments, Dental Hand |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00083208025648]
Moist Heat or Steam Sterilization
[00083208025648]
Moist Heat or Steam Sterilization
[00083208025648]
Moist Heat or Steam Sterilization
[00083208025648]
Moist Heat or Steam Sterilization
[00083208025648]
Moist Heat or Steam Sterilization
[00083208025648]
Moist Heat or Steam Sterilization
[00083208025648]
Moist Heat or Steam Sterilization
[00083208025648]
Moist Heat or Steam Sterilization
[00083208025648]
Moist Heat or Steam Sterilization
[00083208025648]
Moist Heat or Steam Sterilization
[00083208025648]
Moist Heat or Steam Sterilization
[00083208025648]
Moist Heat or Steam Sterilization
[00083208025648]
Moist Heat or Steam Sterilization
[00083208025648]
Moist Heat or Steam Sterilization
[00083208025648]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-17 |
| Device Publish Date | 2021-02-09 |
| 00083208025662 | ITL - HTT .050 driver (Short) |
| 00083208025655 | ITL - HTLT .050 driver (Long) |
| 00083208025648 | ITL latch grip driver - Long - .050 |