Catalog Number

31102020

Brand Name

Action®

Version/Model Number

Bolx I

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 06, 2017

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K811528

Product Code

JAD

Product Code Name

System, Therapeutic, X-Ray

Public Device Record Key

0c86d214-54c8-444a-93b5-96e0c0f3fbcd

Public Version Date

March 24, 2021

Public Version Number

3

DI Record Publish Date

February 06, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-