Catalog Number

-

Brand Name

Axiom® CWV Facial Atraum™ With ClotStop®

Version/Model Number

410ATSX

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

K883887,K883887,K883887

Product Code

GBS

Product Code Name

Catheter, Ventricular, General & Plastic Surgery

Public Device Record Key

718df0c9-3f46-4409-886d-4182962c3fed

Public Version Date

March 08, 2022

Public Version Number

2

DI Record Publish Date

July 01, 2021

Package DI Number

M665410ATSX1

Quantity per Package

10

Contains DI Package

M665410ATSX0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box