AccessGUDID - DEVICE: Irisbond (G783OSKOL20)

GUDID

Device Identifier (DI) Information

Brand Name: Irisbond
Version or Model: Oskol2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: IRISBOND CROWDBONDING SL.

Primary DI Number: G783OSKOL20
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 465408652 *Terms of Use

Device Description: Oskol 2 is an Augmentative and Alternative Communication system. Oskol 2 provides a communication tool for people with oral communication difficulties, especially those with severe motor disabilities who cannot use conventional mouse-based systems. People with conditions such as Amyotrophic Lateral Sclerosis (ALS) or Cerebral Palsy can access various applications installed on the computer using Oskol 2. Oskol 2 is specifically designed for use with gaze interaction. It incorporates an eye tracker that estimates the point on the screen where the user is looking. This allows the on-screen pointer to move in time with the user's gaze, replacing traditional mouse or touch interactions. Augmentative and Alternative Communication (AAC) tools allow users to communicate effectively.

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):	No
Over the Counter (OTC):	No
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
Storage Environment Temperature: between 0 and 45 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bae829f0-68f1-4540-9620-2c7c1e6cda1c
Public Version Date: August 11, 2025
Public Version Number: 1
DI Record Publish Date: August 01, 2025