Duns Number:341467978
Device Description: Flexible Video Rhino Laryngoscope, diameter flexible end 2,9 mm
Catalog Number
M-205-22031-0101
Brand Name
Flexible Video Rhino Laryngoscope
Version/Model Number
RSX-P
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 19, 2020
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K150248
Product Code
EQN
Product Code Name
Laryngoscope, Nasopharyngoscope
Public Device Record Key
0ef6f68c-4ac5-4ea4-80c2-034ce9fdc8da
Public Version Date
October 20, 2020
Public Version Number
2
DI Record Publish Date
March 06, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |