Duns Number:793517660
Device Description: The Defogging and Cleaning Solution is a single-use laparoscopic accessory device intended The Defogging and Cleaning Solution is a single-use laparoscopic accessory device intended to facilitate intra-operative defogging and cleaning of the lens of a laparoscope during minimally invasive surgery while maintaining visualization of the surgical site.
Catalog Number
FX10
Brand Name
Flo-X
Version/Model Number
FX10
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OCT
Product Code Name
Anti Fog Solution And Accessories, Endoscopy
Public Device Record Key
7b9c98bf-2670-4608-9072-4b84f67be2bd
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 25, 2016
Package DI Number
10815128020659
Quantity per Package
6
Contains DI Package
00815128020652
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Sales Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |