Catalog Number

-

Brand Name

Syntrax Support Catheter

Version/Model Number

18-180

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"

-

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

K200317

Product Code

DQY

Product Code Name

Catheter, percutaneous

Public Device Record Key

76c47719-1803-482d-b815-92fc7a505c91

Public Version Date

December 24, 2021

Public Version Number

1

DI Record Publish Date

December 16, 2021

Package DI Number

H787181801

Quantity per Package

5

Contains DI Package

H787181800

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX