Catalog Number

040133

Brand Name

BiomarC ®

Version/Model Number

040133

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

90b82f6a-2a5d-42dc-9ec3-21c5f5774191

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

August 18, 2015

Package DI Number

10858015005070

Quantity per Package

10

Contains DI Package

00858015005073

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton