Catalog Number

405120

Brand Name

SJM™

Version/Model Number

405120

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

K791129,K791129

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

82a86785-95c3-4ac2-b4ba-b26cf0771207

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

December 14, 2015

Package DI Number

15415067020939

Quantity per Package

5

Contains DI Package

05415067020932

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-