Duns Number:092364462
Device Description: Solution: Actifog w/Foam Pad 48/Cs
Catalog Number
-
Brand Name
ActiFog™
Version/Model Number
6505
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
f413a619-c546-40b6-8618-f8c3242d01da
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 20, 2016
Package DI Number
20809160022754
Quantity per Package
48
Contains DI Package
10809160022757
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 | 548 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2798 |
| U | Unclassified | 1 |