Duns Number:038000253
Device Description: 15.5F X 19CM SYMETREX® LONG TERM HEMODIALYSIS CATHETER SET W/SYLETS (CUFF 19CM FROM TIP)
Catalog Number
MBPS019
Brand Name
SYMETREX® LTHD CATHETER
Version/Model Number
MBPS019
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"
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
K202176,K202176
Product Code
MSD
Product Code Name
Catheter, hemodialysis, implanted
Public Device Record Key
977d7984-80b6-4808-84c4-c52ce6890d17
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
December 10, 2020
Package DI Number
50884908156916
Quantity per Package
5
Contains DI Package
00884908156911
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 | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2560 |