Duns Number:071595540
Device Description: YANKAUER Suction Instrument Control Vent, Standard Tip W/6 Foot(1.8m) Tubing
Catalog Number
0034920
Brand Name
YANKAUER
Version/Model Number
0034920
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
Yes
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
GCX
Product Code Name
APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
Public Device Record Key
cf4774ec-8509-43d6-931a-56d67f75e712
Public Version Date
April 20, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
20653405000287
Quantity per Package
20
Contains DI Package
10653405000280
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1412 |
2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
3 | A medical device with high risk that requires premarket approval | 95 |