Duns Number:080627691
Device Description: 2222-S Posture-Mate HB 18" Seat Cushion only for wheelchair
Catalog Number
2222-S
Brand Name
Posture-Mate
Version/Model Number
HB 18" Seat Cushion only
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
February 19, 2040
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"
-
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
302c8556-53cb-4371-a848-4f4487054db1
Public Version Date
May 10, 2021
Public Version Number
2
DI Record Publish Date
February 20, 2020
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 | 71 |