Catalog Number

406667

Brand Name

Maximum™

Version/Model Number

406667

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

K870374,K870374

Product Code

DYB

Product Code Name

INTRODUCER, CATHETER

Public Device Record Key

7c57e309-a9a8-4626-b5c5-8d049f875343

Public Version Date

July 08, 2019

Public Version Number

4

DI Record Publish Date

April 10, 2015

Package DI Number

15414734010839

Quantity per Package

5

Contains DI Package

05414734010832

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-