AccessGUDID - DEVICE: NYOrtho Wheelchair Cushion Gel-Foam 22x16x3 (00811677017846)

GUDID

Device Identifier (DI) Information

Brand Name: NYOrtho Wheelchair Cushion Gel-Foam 22x16x3
Version or Model: 9595-GEL-221603
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: N.Y. ORTHOPEDIC USA, INC.

Primary DI Number: 00811677017846
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 612083873 *Terms of Use

Device Description: NYOrtho Gel-Foam Cushions combine a dual chambered gel insert within a dual density foam body. This combination helps prevent pressure injuries, improve patient comfort and correct patient positioning. Features a high-performance stretch cover that improves moisture evaporation with an aggressive non-slip bottom keeping the cushion firmly in place.

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?
11100	Wheelchair seat cushion	A padded device designed to provide support, comfort, and assistance to the occupant of a wheelchair typically by improving posture, providing back and/or side support, compensating for seat height, relieving stress points, and providing pressure alleviation for the buttocks, lumbar region, and the legs, and/or by providing an antislip mechanism. The device is typically situated behind the lower lumbar region of the back or under the buttocks and/or legs while the occupant is seated. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IMP	Cushion, 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: f8be2324-11e8-4fc9-9928-44b3434f424f
Public Version Date: September 11, 2023
Public Version Number: 1
DI Record Publish Date: September 03, 2023