AccessGUDID - DEVICE: MediChoice (10885632063251)

GUDID

Device Identifier (DI) Information

Brand Name: MediChoice
Version or Model: GEY1WL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OWENS & MINOR DISTRIBUTION, INC.

Primary DI Number: 10885632063251
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007941230 *Terms of Use

Device Description: Wheelchair Replacement Wheel Lock Assembly Fits Wheelchairs With Fixed Arms Not Nat Rubber Ltx Non Sterile Reusable MediChoice

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):	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?
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
IML	ARMREST, 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
Special Storage Condition, Specify:
Special Storage Condition, Specify: Protect from water damage, Protect from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f89bc4a9-40eb-4acf-bf9d-bf34559f24e2
Public Version Date: October 21, 2020
Public Version Number: 1
DI Record Publish Date: October 13, 2020