AccessGUDID - DEVICE: Accent 800 TouchGuide 15 Location (00858526006446)

GUDID

Device Identifier (DI) Information

Brand Name: Accent 800 TouchGuide 15 Location
Version or Model: 17347-15
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PRENTKE ROMICH COMPANY

Primary DI Number: 00858526006446
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080143399 *Terms of Use

Device Description: TouchGuides are made from a thin, clear polycarbonate material and precisely engineered to help guide the user’s touch to targeted icons on the screen and reduce accidental activations. TouchGuides allow the Accent 800 / 800-D to be set up to accommodate a wide range of cognitive and motor skills. Using the TouchGuide with the 800 requires the device frame that came with the 800.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILQ	System, Communication, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 75d942a6-c4d4-4223-bc92-4434a93fe7eb
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016