Duns Number:120818216
Device Description: BIOPATCH PEDIATRIC DRESSING KIT
Catalog Number
AMS-8952CP-3
Brand Name
VYGON
Version/Model Number
AMS-8952CP-3
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
Yes
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
OXQ
Product Code Name
Dressing change tray
Public Device Record Key
93bfcdfc-27c9-4ec5-a8fd-d7a02d15b111
Public Version Date
October 06, 2020
Public Version Number
4
DI Record Publish Date
October 10, 2017
Package DI Number
38498840010991
Quantity per Package
20
Contains DI Package
08498840010990
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 124 |
2 | A medical device with a moderate to high risk that requires special controls. | 833 |