Duns Number:007928633
Device Description: Cooley-Madoff Adult Suction Cannula Set w/ 2 Tips 30.5cm 12"
Catalog Number
8215-20
Brand Name
Suction Cannula
Version/Model Number
8215-20
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
aa52a2eb-cf6a-4dcd-bce1-fc8cd296a9c4
Public Version Date
July 04, 2022
Public Version Number
1
DI Record Publish Date
June 24, 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 | 2597 |
2 | A medical device with a moderate to high risk that requires special controls. | 416 |