Duns Number:071595540
Device Description: YANKAUER Suction Instrument without Control Vent, Flexible, Fine Tip, Clear
Catalog Number
0034005
Brand Name
NA
Version/Model Number
0034005
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
e5ead006-05bc-499a-9d84-f592308e7352
Public Version Date
June 10, 2022
Public Version Number
1
DI Record Publish Date
June 02, 2022
Package DI Number
20653405005671
Quantity per Package
50
Contains DI Package
10653405005674
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 |