Duns Number:051798999
Device Description: 9mm Mediastinal – Silicone Catheter
Catalog Number
14809
Brand Name
Silicone Thoracic Catheters
Version/Model Number
14809
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
KGZ
Product Code Name
Accessories, Catheter
Public Device Record Key
63e215db-3744-4818-9fcc-a9fbbcbb46ab
Public Version Date
October 15, 2020
Public Version Number
2
DI Record Publish Date
September 22, 2020
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 | 161 |
2 | A medical device with a moderate to high risk that requires special controls. | 273 |