Duns Number:015903922
Device Description: Curved Sinus Suction, 3.0mm, Long
Catalog Number
1.04.04
Brand Name
mytaMed
Version/Model Number
1.04.04
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
KCB
Product Code Name
Tube, Tonsil Suction
Public Device Record Key
c145bef2-ee7d-49c1-8132-bf8de7a26b22
Public Version Date
April 20, 2020
Public Version Number
4
DI Record Publish Date
February 06, 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 |