Duns Number:243880700
Device Description: Anti-Fog Solution, 6 g solution, 1 sponge, pouch
Catalog Number
AF-100
Brand Name
Anti-Fog Kit
Version/Model Number
AF-100
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
K932449,K932449
Product Code
OCT
Product Code Name
Anti Fog Solution And Accessories, Endoscopy
Public Device Record Key
fffa34ed-34e9-41e1-91a1-07187a5d9971
Public Version Date
July 30, 2018
Public Version Number
1
DI Record Publish Date
June 29, 2018
Package DI Number
00690521014633
Quantity per Package
20
Contains DI Package
00690521014626
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 | 748 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |