AccessGUDID - DEVICE: parawalk 3m with wooden plate (04050588002015)

GUDID

Device Identifier (DI) Information

Brand Name: parawalk 3m with wooden plate
Version or Model: cos30018va01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: cos30018va01
Company Name: h/p/cosmos sports & medical gmbh

Primary DI Number: 04050588002015
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 341362614 *Terms of Use

Device Description: No description.

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?
30926	Parallel bar exerciser, non-powered	An exercise apparatus designed to assist users in maintaining good walking posture, particularly a person with a disability, a paraplegic, or a patient who has suffered a stroke and is learning to walk. It typically consists of two parallel wooden or steel handrails each one supported by two poles and base plates; the user holds the bars, which may be manually height and width-adjustable, thus relieving his/her weight when walking. The device is intended to improve the user?s balance as well as coordination and flexibility; additionally, it can improve the muscle strength in the lower limbs.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IOE	Bars, Parallel, Exercise

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: c715218b-6c5c-4a98-becf-0129c56ffbe0
Public Version Date: January 15, 2020
Public Version Number: 1
DI Record Publish Date: January 07, 2020