Duns Number:867673159
Device Description: Personal CareAids to Daily Living Product Description: Swivel Seat Cushion,Gray,RTL,1EA,8/ Personal CareAids to Daily Living Product Description: Swivel Seat Cushion,Gray,RTL,1EA,8/CS
Catalog Number
-
Brand Name
DRIVEMEDICAL
Version/Model Number
RTLFW19RW-RD
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"
-
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
IKX
Product Code Name
AID, TRANSFER
Public Device Record Key
98ffc3ad-4711-47b0-9151-fc089ed3c953
Public Version Date
August 05, 2022
Public Version Number
4
DI Record Publish Date
May 19, 2017
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 | 3783 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 832 |