AccessGUDID - DEVICE: Everest & Jennings (M36890763050A1)

GUDID

Device Identifier (DI) Information

Brand Name: Everest & Jennings
Version or Model: 90763050A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 90763050A
Company Name: GF HEALTH PRODUCTS, INC.

Primary DI Number: M36890763050A1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 132016168 *Terms of Use

Device Description: 24" X 1" WHEEL & BLACK HANDRIM W/HUBCAP TRAV SE PLUS

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?
36261	Wheelchair wheel	A circular frame of metal and/or synthetic materials which turns on a central axle that is attached to the body of a wheelchair to enable the wheelchair to move when propelled. It comes in a variety of designs, diameters and weights, and is typically fitted with a tyre (tire); brackets for mounting the wheel onto the wheelchair may be included with the device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNN	Components, 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: 0e547ece-007c-43ce-922e-f06e2fb276cd
Public Version Date: October 27, 2020
Public Version Number: 1
DI Record Publish Date: October 19, 2020