Accent 800 TouchGuide 8 Location
- Primary DI
- 00858526006453
- Brand
- Accent 800 TouchGuide 8 Location
- Company
- PRENTKE ROMICH COMPANY
- Model
- 17347-8
- Device description
- Keyguards are made from thick, clear polycarbonate material and precisely engineered to help guide the user’s touch to targeted icons on the screen and reduce accidental activations. Keyguards allow the Accent 800/800-D to be set up to accommodate a wide range of cognitive and motor skills. Using the Keyguard with the 800 requires the device frame that came with the 800. If a replacement frame is needed please go to (insert link to 800 Device Frame) These keyguards have rectangular openings as shown in the picture and are made from clear .183" thick polycarbonate.
- Published
- 2016-09-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- true
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| ILQ | System, Communication, Powered |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| ILQ | System, Communication, Powered | Physical Medicine | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00858526006453 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00858526006453 | 00858526006453 | 858526006453 | 0858526006453 |
GMDN Terms
| Term | Definition |
|---|
| Voice synthesizer/digitizer | An assistive device designed to deliver voice output based either in the reproduction of previously-recorded natural speech and/or on an electronic synthesized voice following a pre-established set of pronunciation rules. It typically consists of an electronic unit with a keyboard and screen; the keyboard may include letters, symbols, or both. The device is often customized to meet the user?s needs and is mostly used by patients with disabilities that partially or totally impair voice capabilities, including chronic progressive diseases. |
Regulatory Flags
- DUNS number
- 080143399
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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