AccessGUDID - DEVICE: Bioness Integrated System (BITS) Mobile Configuration (00815962020214)

GUDID

Device Identifier (DI) Information

Brand Name: Bioness Integrated System (BITS) Mobile Configuration
Version or Model: BIT-2224
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIONESS INC.

Primary DI Number: 00815962020214
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 182287727 *Terms of Use

Device Description: Bioness Integrated Therapy System, Version 2.0, Mobile Configuration, 24" Display with Software

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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:	Yes
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?
30908	Perceptual-coordination assistive training device	A device designed to help train a person with a disability to improve their ability to correctly process and coordinate external stimuli, especially those relating to concepts of space and time, spatial concepts, and eye-hand coordination.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKK	SYSTEM, ISOKINETIC TESTING AND EVALUATION

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: 61d31ddb-0f30-4734-9e8c-092b9d116a39
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: July 10, 2017