Duns Number:317326411
Device Description: cleaning sheath sinuscope
Catalog Number
8300055818
Brand Name
Cleaning sheath for Ø4mm X 155mm 30° R
Version/Model Number
8300055818
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KMA
Product Code Name
Irrigator, Powered Nasal
Public Device Record Key
751ea367-cb9b-465f-b56d-ac708ccab15c
Public Version Date
May 09, 2022
Public Version Number
1
DI Record Publish Date
May 01, 2022
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 | 40 |
2 | A medical device with a moderate to high risk that requires special controls. | 77 |