Duns Number:832696038
Device Description: FRAZIER-PAPARELLA MASTOID SUCTION TUBE 7FR, NO 1, WITH FINGER VALVE WORKING LENGTH 2-1/4" FRAZIER-PAPARELLA MASTOID SUCTION TUBE 7FR, NO 1, WITH FINGER VALVE WORKING LENGTH 2-1/4" (5.7CM)
Catalog Number
AU13868
Brand Name
V. Mueller
Version/Model Number
AU13868
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
JZF
Product Code Name
TUBE, EAR SUCTION
Public Device Record Key
f121fea4-17d8-4732-ad07-ff8f259492c6
Public Version Date
April 20, 2020
Public Version Number
3
DI Record Publish Date
July 13, 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 | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |