Catalog Number

-

Brand Name

Axiom®

Version/Model Number

100024S

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

58b4a174-4b6a-46ac-80d6-3fe540db6ea2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

M665100024S3

Quantity per Package

10

Contains DI Package

M665100024S1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case