Catalog Number

405128

Brand Name

SJM™

Version/Model Number

405128

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

K894431,K894431

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

b0b1bbaa-580f-4456-87b6-9d0675f46940

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

December 03, 2015

Package DI Number

15415067020960

Quantity per Package

5

Contains DI Package

05415067020963

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-