Duns Number:067543058
Device Description: Adaptive Pebble Pad
Catalog Number
P181805
Brand Name
Action®
Version/Model Number
Adaptive Pad
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
KIC
Product Code Name
Cushion, Flotation
Public Device Record Key
dc3861a0-76c6-4a1a-acb9-782a353d45ff
Public Version Date
February 17, 2021
Public Version Number
1
DI Record Publish Date
February 09, 2021
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 | 993 |
2 | A medical device with a moderate to high risk that requires special controls. | 49 |