Duns Number:073189370
Device Description: Anasept® Antimicrobial Skin and Wound Cleanser is a clear, isotonic liquid that helps in t
Catalog Number
4012SC
Brand Name
Anasept Antimicrobial Skin and Wound Cleanser
Version/Model Number
4012SC
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)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K073547,K073547
Product Code
FQH
Product Code Name
Lavage, Jet
Public Device Record Key
bae9f8fb-1b02-48c1-8499-36007ea8d074
Public Version Date
July 28, 2020
Public Version Number
2
DI Record Publish Date
June 08, 2020
Package DI Number
00367180412123
Quantity per Package
12
Contains DI Package
00367180400120
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |
| U | Unclassified | 3 |