Duns Number:008124539
Device Description: Bariatric Gel/Foam Cushion 24"x18"x3"
Catalog Number
-
Brand Name
Bariatric Gel/Foam Cushion 24"x18"x3"
Version/Model Number
13051
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"
Yes
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
6ef4bf51-173f-49d4-9a73-45c6ae34ce63
Public Version Date
July 19, 2022
Public Version Number
2
DI Record Publish Date
April 22, 2021
Package DI Number
00840117321137
Quantity per Package
5
Contains DI Package
00840117321106
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |