Catalog Number

-

Brand Name

Axiom®

Version/Model Number

3610

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

-

Product Code

GBS

Product Code Name

Catheter, Ventricular, General & Plastic Surgery

Public Device Record Key

b6bdde33-35b9-4f8b-a36e-348b6094482f

Public Version Date

November 23, 2020

Public Version Number

1

DI Record Publish Date

November 13, 2020

Package DI Number

M66536101

Quantity per Package

10

Contains DI Package

M66536100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box