Duns Number:073189370
Device Description: Anasept® Antimicrobial Wound Irrigation Solution is a clear, isotonic liquid that helps in
Catalog Number
4160IC
Brand Name
Anasept Antimicrobial Wound Irrigation Solution
Version/Model Number
4160IC
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)
Yes
Over the Counter (OTC)
-
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
9ad6a723-f272-4cae-82b1-c4596459948a
Public Version Date
June 30, 2020
Public Version Number
1
DI Record Publish Date
June 22, 2020
Package DI Number
00367180426168
Quantity per Package
12
Contains DI Package
00367180416169
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 |