Catalog Number

405512

Brand Name

SJM™

Version/Model Number

405512

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

K894330,K894330

Product Code

DRE

Product Code Name

DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Public Device Record Key

b1410570-560d-4411-8c8a-5a38a6dca161

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 04, 2015

Package DI Number

15414734053713

Quantity per Package

10

Contains DI Package

05414734053716

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-