Duns Number:090266979
Device Description: A sterile kit containing a 6cc vial of anti-fog solution and sponge with radiopaque marker A sterile kit containing a 6cc vial of anti-fog solution and sponge with radiopaque marker, pack of 10
Catalog Number
-
Brand Name
ClearIt Anti-Fog Kit
Version/Model Number
PS003
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
K022826,K022826,K022826
Product Code
OCT
Product Code Name
Anti Fog Solution And Accessories, Endoscopy
Public Device Record Key
ecf4aac4-332c-4014-a814-50fc193742ab
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 11, 2016
Package DI Number
20810805000143
Quantity per Package
60
Contains DI Package
10810805000146
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |