Duns Number:058614483
Device Description: Precision RT Chronic Catheter Kit,Symmetrical Tip, Reverse-Tunneled,15 Fr/Ch (5.0 mm) x 28 Precision RT Chronic Catheter Kit,Symmetrical Tip, Reverse-Tunneled,15 Fr/Ch (5.0 mm) x 28 cm
Catalog Number
-
Brand Name
Palindrome
Version/Model Number
8888541028P
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 18, 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"
-
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,K123196
Product Code
MSD
Product Code Name
Catheter, hemodialysis, implanted
Public Device Record Key
f5f3cc45-bc3b-4457-9ac6-32b14f5e041c
Public Version Date
September 05, 2022
Public Version Number
5
DI Record Publish Date
September 22, 2014
Package DI Number
20884521158518
Quantity per Package
5
Contains DI Package
10884521158511
Package Discontinue Date
March 31, 2021
Package Status
Not in Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| 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 |