Catalog Number

040165

Brand Name

BIOMARC ® EX

Version/Model Number

040165

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

K132064,K132064

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

9dc853d5-184c-4c70-b36e-ce86af33e139

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

February 07, 2022

Package DI Number

10850002461302

Quantity per Package

3

Contains DI Package

00850002461305

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON