AccessGUDID - DEVICE: MediChoice (10885632142550)

GUDID

Device Identifier (DI) Information

Brand Name: MediChoice
Version or Model: GEY2HDCA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OWENS & MINOR DISTRIBUTION, INC.

Primary DI Number: 10885632142550
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007941230 *Terms of Use

Device Description: Wheelchair Replacement Front Caster Assembly Includes Pneumatic Casters Fork Assembly And All Hardware Fits All MediChoice 22-24 Inch Heavy Duty Wheelchairs 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?
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
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: Protect from water damage, Protect from sunlight
Special Storage Condition, Specify:

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 676e57bc-5197-4010-a762-f677b326454c
Public Version Date: October 21, 2020
Public Version Number: 1
DI Record Publish Date: October 13, 2020