AccessGUDID - DEVICE: Cane/Crutch Holder (00606509800013)

GUDID

Device Identifier (DI) Information

Brand Name: Cane/Crutch Holder
Version or Model: Cane/Crutch Holder
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N/A
Company Name: PRIDE MOBILITY PRODUCTS CORPORATION

Primary DI Number: 00606509800013
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 041477449 *Terms of Use

Device Description: A wheelchair accessory is a device intended for medical purposes that is sold separately from a wheelchair and is intended to meet the specific needs of a patient who uses a wheelchair. The Cane/Crutch Holder is an accessory that mounts to a medical device to hold canes or crutches.

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":	Yes
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

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

GMDN Preferred Term Name	GMDN Definition
Wheelchair crutch/walking stick holder	A cylinder, tube, or bag-like device that is mounted on a wheelchair to provide the wheelchair's occupant with a receptacle or holder for a crutch or a walking stick (cane).

FDA Product Code

[?]

Product Code	Product Code Name
IMZ	Holder, Crutch And Cane, 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: 04650bf7-b6ec-4539-9234-00050fe5b25b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 19, 2016