Duns Number:017283879
Device Description: The FocESS HD Wireless Camera is indicated for use in endoscopic procedures to allow visua The FocESS HD Wireless Camera is indicated for use in endoscopic procedures to allow visualization of the nasal and sinus cavities when used with an appropriately indicated endoscope. The Wireless Camera is provided non-sterile and is not intended for use in the sterile field.
Catalog Number
WCS-100
Brand Name
FocESS HD Wireless Camera
Version/Model Number
WCS
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
-
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
-
Product Code
FWL
Product Code Name
Camera, Cine, Endoscopic, Without Audio
Public Device Record Key
d826fd3c-9c2b-4888-b4d2-c1a21e5df2c4
Public Version Date
September 28, 2020
Public Version Number
1
DI Record Publish Date
September 18, 2020
Package DI Number
10857326005564
Quantity per Package
1
Contains DI Package
00857326005567
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |