Catalog Number

-

Brand Name

Axiom®

Version/Model Number

100040SC

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K770983,K770983,K770983

Product Code

JOL

Product Code Name

Catheter And Tip, Suction

Public Device Record Key

219f6000-486e-4773-a361-f6a2c83e4418

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

M665100040SC3

Quantity per Package

10

Contains DI Package

M665100040SC1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case