| Primary Device ID | 10866330000205 |
| NIH Device Record Key | cdd488ae-8dea-4fbf-94f7-343a80bbbbc7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmartGuard |
| Version Model Number | SGDG6 |
| Company DUNS | 079556398 |
| Company Name | Smartguard Rx, Inc. |
| 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 | 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 | true |
| Phone | 1-855-576-2785 |
| brian@smartguardrx.com | |
| Phone | 1-855-576-2785 |
| brian@smartguardrx.com | |
| Phone | 1-855-576-2785 |
| brian@smartguardrx.com | |
| Phone | 1-855-576-2785 |
| brian@smartguardrx.com | |
| Phone | 1-855-576-2785 |
| brian@smartguardrx.com | |
| Phone | 1-855-576-2785 |
| brian@smartguardrx.com | |
| Phone | 1-855-576-2785 |
| brian@smartguardrx.com | |
| Phone | 1-855-576-2785 |
| brian@smartguardrx.com | |
| Phone | 1-855-576-2785 |
| brian@smartguardrx.com | |
| Phone | 1-855-576-2785 |
| brian@smartguardrx.com | |
| Phone | 1-855-576-2785 |
| brian@smartguardrx.com | |
| Phone | 1-855-576-2785 |
| brian@smartguardrx.com | |
| Phone | 1-855-576-2785 |
| brian@smartguardrx.com | |
| Phone | 1-855-576-2785 |
| brian@smartguardrx.com | |
| Phone | 1-855-576-2785 |
| brian@smartguardrx.com | |
| Phone | 1-855-576-2785 |
| brian@smartguardrx.com | |
| Phone | 1-855-576-2785 |
| brian@smartguardrx.com | |
| Phone | 1-855-576-2785 |
| brian@smartguardrx.com | |
| Phone | 1-855-576-2785 |
| brian@smartguardrx.com | |
| Phone | 1-855-576-2785 |
| brian@smartguardrx.com | |
| Phone | 1-855-576-2785 |
| brian@smartguardrx.com | |
| Phone | 1-855-576-2785 |
| brian@smartguardrx.com | |
| Phone | 1-855-576-2785 |
| brian@smartguardrx.com | |
| Phone | 1-855-576-2785 |
| brian@smartguardrx.com | |
| Phone | 1-855-576-2785 |
| brian@smartguardrx.com | |
| Phone | 1-855-576-2785 |
| brian@smartguardrx.com | |
| Phone | 1-855-576-2785 |
| brian@smartguardrx.com | |
| Phone | 1-855-576-2785 |
| brian@smartguardrx.com | |
| Phone | 1-855-576-2785 |
| brian@smartguardrx.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00866330000208 [Primary] |
| GS1 | 10866330000205 [Package] Contains: 00866330000208 Package: Inner Pack [3 Units] In Commercial Distribution |
| GS1 | 20866330000202 [Package] Package: Inner pack [4 Units] In Commercial Distribution |
| GS1 | 30866330000209 [Package] Contains: 00866330000208 Package: Master case no Inner [12 Units] In Commercial Distribution |
| OBR | Mouthguard, Over-The-Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-02 |
| Device Publish Date | 2020-09-24 |
| 10866330000205 | Dental mouth guard for clenching and grinding teeth (bruxism) |
| 00866330000260 | Mandibular Advancement Device to reduce snoring |