Catalog Number

040126

Brand Name

BiomarC®

Version/Model Number

040126

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

K130678,K130678

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

58c3c73d-8b92-469b-9c09-b647c18468fc

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2015

Package DI Number

10858015005193

Quantity per Package

3

Contains DI Package

00858015005196

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton