Catalog Number

384822

Brand Name

Safety MST Accessory Kit

Version/Model Number

384822

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

K974543,K974543

Product Code

FOZ

Product Code Name

Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

Public Device Record Key

24ca2c01-21f5-445c-a9fd-5465ca845a29

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

20886333210057

Quantity per Package

10

Contains DI Package

00886333210053

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box