Catalog Number

-

Brand Name

Axiom® PVC

Version/Model Number

511016

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

K841593,K841593,K841593

Product Code

GBS

Product Code Name

Catheter, Ventricular, General & Plastic Surgery

Public Device Record Key

e3cadf5a-5b6c-48fb-ad02-d2e440009dd7

Public Version Date

October 24, 2018

Public Version Number

1

DI Record Publish Date

September 23, 2018

Package DI Number

M6655110163

Quantity per Package

6

Contains DI Package

M6655110161

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case