Catalog Number

406311

Brand Name

SJM™

Version/Model Number

406311

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

K884494,K884494

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

e3b03673-0792-4c7e-86f9-0873f7b2413f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 15, 2015

Package DI Number

15414734022498

Quantity per Package

10

Contains DI Package

05414734022491

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-