AccessGUDID - DEVICE: WHEELCHAIR BRAKES (00606509900201)

GUDID

Device Identifier (DI) Information

Brand Name: WHEELCHAIR BRAKES
Version or Model: WHEELCHAIR BRAKES
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N/A
Company Name: Pride Mobility Products Corp

Primary DI Number: 00606509900201
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 041477449 *Terms of Use

Device Description: A device consisting of a lever(s), spring(s), tyre contact pads, or other mechanism used to slow down, stop, and/or hold a wheelchair in a stationary position. This also includes the necessary installation package.

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?
31158	Wheelchair brakes	A device consisting of a lever(s), spring(s), tyre contact pads, or other mechanism used to slow down, stop, and/or hold a wheelchair in a stationary position. This GMDN code also includes the necessary installation package.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IMW	Brake, Extension, Wheelchair

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: d64fb02b-662c-4a10-9ab0-d1c0d9fa70ae
Public Version Date: March 03, 2023
Public Version Number: 2
DI Record Publish Date: August 26, 2019