Duns Number:612083873
Device Description: NYOrtho Gel-Foam Cushions combine a dual chambered gel insert within a dual density foam b 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.
Catalog Number
-
Brand Name
NYOrtho Wheelchair Cushion Gel-Foam 18x16x3
Version/Model Number
9595-GEL-181603
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IMP
Product Code Name
Cushion, Wheelchair
Public Device Record Key
1c08d565-947f-4a85-9c0b-ffe327c62aec
Public Version Date
August 19, 2022
Public Version Number
1
DI Record Publish Date
August 11, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |