Duns Number:420944524
Device Description: Yankauer Handle Clear High Capacity w/o Vent
Catalog Number
-
Brand Name
Tiger Medical Products
Version/Model Number
UYT412
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"
Yes
For Single-Use
Yes
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
JOL
Product Code Name
Catheter And Tip, Suction
Public Device Record Key
d088d36e-ea14-4b68-9603-bddfe9f94fea
Public Version Date
April 20, 2020
Public Version Number
3
DI Record Publish Date
October 01, 2016
Package DI Number
10840216101484
Quantity per Package
50
Contains DI Package
00840216101487
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 3 |