Primary Device ID | 00860011903901 |
NIH Device Record Key | 4c7b3dbc-d42e-4e7d-8856-1d186e11a4f9 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | G13 |
Version Model Number | GP13A-G13 |
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 | 00860011903901 [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 | 2024-03-28 |
Device Publish Date | 2024-03-20 |
00860011903901 - G13 | 2024-03-28G13 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 |
B925TS08EL80 - L8 Slimline | 2023-10-04 L8 Slimline Speech Generating Device |
B925TS10EL100 - L10.2 Slimline | 2023-10-04 L10.2 Slimline Speech Generating Device |
B925TS10HL100 - L10 Slimline | 2023-10-04 L10.9 Slimline Speech Generating Device |