| Primary Device ID | 00083208130250 |
| NIH Device Record Key | 1ba18635-5083-4d04-a7a8-9917cf744ffa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Retractor - Tongue and Cheek |
| Version Model Number | Retractor T&C Small |
| Catalog Number | Retractor T&C Small |
| 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 | 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 | 727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 727-536-4880 |
| tatumcompliance@gmail.com | |
| Phone | 727-536-4880 |
| tatumcompliance@gmail.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00083208130250 [Primary] |
| EIG | Retractor, All Types |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00083208130250]
Moist Heat or Steam Sterilization
[00083208130250]
Moist Heat or Steam Sterilization
[00083208130250]
Moist Heat or Steam Sterilization
[00083208130250]
Moist Heat or Steam Sterilization
[00083208130250]
Moist Heat or Steam Sterilization
[00083208130250]
Moist Heat or Steam Sterilization
[00083208130250]
Moist Heat or Steam Sterilization
[00083208130250]
Moist Heat or Steam Sterilization
[00083208130250]
Moist Heat or Steam Sterilization
[00083208130250]
Moist Heat or Steam Sterilization
[00083208130250]
Moist Heat or Steam Sterilization
[00083208130250]
Moist Heat or Steam Sterilization
[00083208130250]
Moist Heat or Steam Sterilization
[00083208130250]
Moist Heat or Steam Sterilization
[00083208130250]
Moist Heat or Steam Sterilization
[00083208130250]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-11 |
| Device Publish Date | 2021-02-03 |
| 00083208130250 | Tongue and cheek retractor is used to hold cheeks, lips, and tongue away from the surgical area |
| 00083208130243 | Tongue and cheek retractor is used to hold cheeks, lips, and tongue away from the surgical area |