Duns Number:038000253
Device Description: 15.5F X 19CM SYMETREX® LONG TERM HEMODIALYSIS CATHETER SPORT PACK W/STYLETS (CUFF 19CM FRO 15.5F X 19CM SYMETREX® LONG TERM HEMODIALYSIS CATHETER SPORT PACK W/STYLETS (CUFF 19CM FROM TIP)
Catalog Number
MSPS019
Brand Name
SYMETREX® LTHD CATHETER
Version/Model Number
MSPS019
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 06, 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
K202176,K202176
Product Code
MSD
Product Code Name
Catheter, hemodialysis, implanted
Public Device Record Key
0a8059d1-b17f-45ad-b6a3-358a90d6a2ac
Public Version Date
December 13, 2021
Public Version Number
3
DI Record Publish Date
December 15, 2020
Package DI Number
50884908157043
Quantity per Package
5
Contains DI Package
00884908157048
Package Discontinue Date
December 06, 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 |