Duns Number:080935429
Device Description: Wheelchair Pad
Catalog Number
31167503
Brand Name
Devon
Version/Model Number
31167503
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KNO
Product Code Name
ACCESSORIES, WHEELCHAIR
Public Device Record Key
3c552d7e-ac87-4c6c-9bd5-43e6380e99c1
Public Version Date
February 15, 2019
Public Version Number
2
DI Record Publish Date
June 23, 2018
Package DI Number
20884527023698
Quantity per Package
12
Contains DI Package
10884527023691
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 672 |
2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
U | Unclassified | 17 |