Catalog Number

040240

Brand Name

BiomarC®

Version/Model Number

040240

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

GDW

Product Code Name

Staple, Implantable

Public Device Record Key

ad21d951-d3c6-4458-a27b-05d0597b57c3

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

November 17, 2015

Package DI Number

10858015005599

Quantity per Package

10

Contains DI Package

00858015005592

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton