Duns Number:058614483
Device Description: Precision SI Chronic Catheter Kit,Symmetrical Tip, Silver Ion Sleeve,14.5 Fr/Ch (4.8 mm) x Precision SI Chronic Catheter Kit,Symmetrical Tip, Silver Ion Sleeve,14.5 Fr/Ch (4.8 mm) x 44 cm
Catalog Number
8888146144CP
Brand Name
Palindrome
Version/Model Number
8888146144CP
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
K123196
Product Code
MSD
Product Code Name
Catheter, hemodialysis, implanted
Public Device Record Key
1898ff35-37dd-4b2e-bdc8-d56aed54ec01
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
September 22, 2014
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 | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |