Catalog Number

040119

Brand Name

BiomarC®

Version/Model Number

040119

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 11, 2017

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

NEU

Product Code Name

Marker, Radiographic, Implantable

Public Device Record Key

999a39f9-c95d-4dd7-8b4b-8fbd69602265

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

September 24, 2015

Package DI Number

10858015005148

Quantity per Package

3

Contains DI Package

00858015005141

Package Discontinue Date

December 11, 2017

Package Status

Not in Commercial Distribution

Package Type

Carton