Duns Number:027680821
Device Description: Intended to be used as an anti-fog agent for endoscopic camera lenses
Catalog Number
-
Brand Name
Dr. Fog® Anti-fog Solution
Version/Model Number
DF-3100B
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 07, 2022
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
-
Product Code
OCT
Product Code Name
Anti fog solution and accessories, endoscopy
Public Device Record Key
91a9a333-63a7-4e97-8824-c0ced1044255
Public Version Date
October 14, 2022
Public Version Number
6
DI Record Publish Date
September 17, 2016
Package DI Number
20887761000036
Quantity per Package
15
Contains DI Package
10887761000039
Package Discontinue Date
July 07, 2022
Package Status
Not 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 | 952 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 494 |