Duns Number:078843940
Device Description: Skin and wound cleanser.
Catalog Number
15108
Brand Name
ExSept Plus
Version/Model Number
250 mL
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K082858,K082858
Product Code
FQH
Product Code Name
Lavage, Jet
Public Device Record Key
d74a81da-cc46-4783-a0f1-2b6052357fc2
Public Version Date
May 19, 2020
Public Version Number
4
DI Record Publish Date
August 29, 2016
Package DI Number
20898021000086
Quantity per Package
24
Contains DI Package
00898021000082
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. | 11 |