Catalog Number

-

Brand Name

AXS Universal Liner Set with Solidifier

Version/Model Number

101035340

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

BTA

Product Code Name

Pump, Portable, Aspiration (Manual Or Powered)

Public Device Record Key

3c943a5a-7f13-43cf-a211-d51cf9e461d6

Public Version Date

January 08, 2021

Public Version Number

5

DI Record Publish Date

June 07, 2018

Package DI Number

07612367061858

Quantity per Package

6

Contains DI Package

07612367060608

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-