Duns Number:038000253
Device Description: 12F X 15CM SILICONE SINGLE LUMEN CATHETER SET W/STYLET
Catalog Number
-
Brand Name
LONG TERM CVC
Version/Model Number
SSL1215M
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 29, 2021
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"
Yes
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
DQO
Product Code Name
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Public Device Record Key
8b021012-79d6-44da-87a9-64481a87ee43
Public Version Date
February 19, 2021
Public Version Number
7
DI Record Publish Date
June 15, 2016
Package DI Number
50884908049515
Quantity per Package
10
Contains DI Package
00884908049510
Package Discontinue Date
January 29, 2021
Package Status
Not 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 | 31 |
2 | A medical device with a moderate to high risk that requires special controls. | 2560 |