Catalog Number

-

Brand Name

Synergy

Version/Model Number

KIT-400-51

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

K101329,K101329,K101329

Product Code

LJS

Product Code Name

Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days

Public Device Record Key

8fed3eb8-f53f-4f4c-917e-75225f31b116

Public Version Date

February 19, 2021

Public Version Number

4

DI Record Publish Date

October 23, 2015

Package DI Number

10876604000589

Quantity per Package

5

Contains DI Package

00876604000582

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner