Catalog Number

-

Brand Name

Axiom® Petite® CWV

Version/Model Number

201

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

K965146,K965146,K965146

Product Code

GBX

Product Code Name

Catheter, Irrigation

Public Device Record Key

66e11e46-de02-485c-aedf-d796825fa5d8

Public Version Date

March 08, 2022

Public Version Number

2

DI Record Publish Date

September 23, 2018

Package DI Number

M6652013

Quantity per Package

10

Contains DI Package

M6652011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case