Accent 800 TouchGuide 8 Location

Basic Information

• Brand Name: Accent 800 TouchGuide 8 Location
• Primary DI: 00858526006453
• Version / Model: 17347-8
• Company Name: PRENTKE ROMICH COMPANY
• Labeler DUNS: 080143399
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 0150dc49-799f-4e28-9ee7-89c1283e3435

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ILQ	System, Communication, Powered	Physical Medicine	890.3710	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17187	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858526006453	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]