Duns Number:038000253
Device Description: 15.5F X 37CM SYMETREX® LONG TERM HEMODIALYSIS CATHETER SPORT PACK W/O STYLETS (CUFF 37CM F 15.5F X 37CM SYMETREX® LONG TERM HEMODIALYSIS CATHETER SPORT PACK W/O STYLETS (CUFF 37CM FROM TIP)
Catalog Number
MSNS037
Brand Name
SYMETREX® LTHD CATHETER
Version/Model Number
MSNS037
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 28, 2022
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
6e49b255-7359-43e6-b69f-23aa8ed76450
Public Version Date
May 10, 2022
Public Version Number
3
DI Record Publish Date
December 21, 2020
Package DI Number
50884908156695
Quantity per Package
5
Contains DI Package
00884908156690
Package Discontinue Date
April 28, 2022
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 |