Catalog Number

040138

Brand Name

BiomarC®

Version/Model Number

040138

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K132708

Product Code

NEU

Product Code Name

Marker, Radiographic, Implantable

Public Device Record Key

e09b3c86-4c5d-4627-b2d2-581953526aec

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

August 07, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-