Duns Number:094439676
Device Description: Thoracic Catheter, Right Angle, Silicone, With Scale
Catalog Number
-
Brand Name
Axiom®
Version/Model Number
111128S
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K770983,K770983,K770983
Product Code
JOL
Product Code Name
Catheter And Tip, Suction
Public Device Record Key
045c8ff7-b80b-4c54-85b3-d2a51ad04251
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
M665111128S3
Quantity per Package
6
Contains DI Package
M665111128S1
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 187 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 131 |