AccessGUDID - DEVICE: RehaCom Cognitive Therapy Panel, RehaCom Keyboard (04260397620960)

GUDID

Device Identifier (DI) Information

Brand Name: RehaCom Cognitive Therapy Panel, RehaCom Keyboard
Version or Model: Reha0099
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Reha0099
Company Name: HASOMED GmbH

Primary DI Number: 04260397620960
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 341439008 *Terms of Use

Device Description: RehaCom Keyboard

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):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Assistive keyboard-skill training device	A device designed to help train a disabled person to control the function (operation) of a keyboard to enable operation of a connected primary device (e.g., a computer or another assistive keyboard-dependent device).

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: 4d94adba-1e71-47e9-9430-5b284aa64981
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 26, 2016