Catalog Number

-

Brand Name

Axiom® MultiPurpose Atraum™ With ClotStop®

Version/Model Number

110218AT

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

K993592,K993592,K993592

Product Code

BSO

Product Code Name

Catheter, Conduction, Anesthetic

Public Device Record Key

b0ae6253-0c96-4e10-b492-782a78990e3e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

M665110218AT3

Quantity per Package

6

Contains DI Package

M665110218AT1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case