| Primary Device ID | 00860011903970 |
| NIH Device Record Key | a49af37c-7295-4044-9c7b-d4c36f9e8796 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | G10x Slimline |
| Version Model Number | SS10E |
| Company DUNS | 047962036 |
| Company Name | Smartbox Assistive Technology 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 | 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860011903970 [Primary] |
| ILQ | System, Communication, Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-22 |
| Device Publish Date | 2025-01-14 |
| 00860011903970 - G10x Slimline | 2025-01-22G10x Slimline Speech Generating Device |
| 00860011903970 - G10x Slimline | 2025-01-22 G10x Slimline Speech Generating Device |
| 00860011903932 - G10x | 2024-12-05 G10x Speech Generating Device |
| 00860011903949 - G15 | 2024-10-29 G15 Speech Generating Device |
| 00860011903956 - G10 | 2024-10-29 G10 Speech Generating Device |
| 00860011903901 - G13 | 2024-03-28 G13 Speech Generating device |
| B925TP08EL80 - L8 | 2023-10-04 L8 Speech Generating Device |
| B925TP10EL100 - L10.2 | 2023-10-04 L10.2 Speech Generating Device |
| B925TP10HL100 - L10 | 2023-10-04 L10.9 Speech Generating Device |