Duns Number:015903922
Device Description: mytaView Sheath, ac Rigid Sinuscopes
Catalog Number
mV-89538743
Brand Name
mytaMed
Version/Model Number
mV-89538743
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
-
Product Code
FFY
Product Code Name
Adaptor, Bulbs, Miscellaneous, For Endoscope
Public Device Record Key
d77af556-f063-49ca-9663-fc2c6b90f7c4
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 16, 2018
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 | 861 |
2 | A medical device with a moderate to high risk that requires special controls. | 21 |