Catalog Number

8888133510P

Brand Name

Palindrome

Version/Model Number

8888133510P

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,K123196

Product Code

MSD

Product Code Name

Catheter, hemodialysis, implanted

Public Device Record Key

ec1c5337-9f13-4fd2-9b67-767c9046ead5

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

September 01, 2014

Package DI Number

20884521157955

Quantity per Package

5

Contains DI Package

10884521157958

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-