Duns Number:604056226
Device Description: Key Surgical Mr. Clear Anti-Fog is indicated for use during endoscopic, laparoscopic, gast Key Surgical Mr. Clear Anti-Fog is indicated for use during endoscopic, laparoscopic, gastroscopic, and arthroscopic procedures, as well as any other procedures which require the use of an endoscope device, to prevent fogging of the endoscope lens.
Catalog Number
AF-031
Brand Name
Key Surgical Mr. Clear Anti-Fog
Version/Model Number
AF-031
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K993604,K993604
Product Code
OCT
Product Code Name
Anti Fog Solution And Accessories, Endoscopy
Public Device Record Key
c3589d7b-2c0a-4e84-ae0d-4a46bc88b4e5
Public Version Date
September 08, 2021
Public Version Number
3
DI Record Publish Date
July 24, 2019
Package DI Number
10849771037856
Quantity per Package
20
Contains DI Package
00849771037859
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 326 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 219 |