Duns Number:170562396
Device Description: 2" Solid seat cushion, w/drop hooks for 24" width chair, burgandy vinyl
Catalog Number
38124S27MR
Brand Name
Assembly Required Distributors
Version/Model Number
UP0810X-01-22
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
0718e32a-e59f-43a5-986e-3c267f8cb997
Public Version Date
May 10, 2021
Public Version Number
2
DI Record Publish Date
March 08, 2018
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 | 81 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |