Duns Number:657476292
Device Description: No description.
Catalog Number
-
Brand Name
DermaAngel Active Patch Intensive
Version/Model Number
AP-SA151-p
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
NAC
Product Code Name
Dressing, Wound, Hydrophilic
Public Device Record Key
07b197fc-1eb5-40ae-bc21-46ff6a1498ce
Public Version Date
September 29, 2022
Public Version Number
1
DI Record Publish Date
September 21, 2022
Package DI Number
04719745108600
Quantity per Package
51
Contains DI Package
04719745108556
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 | 7 |
2 | A medical device with a moderate to high risk that requires special controls. | 12 |