Catalog Number

040155

Brand Name

BiomarC® Restore

Version/Model Number

040155

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

-

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

8ce59b7e-a3b0-4a08-b98a-e0a420ca2eab

Public Version Date

October 04, 2022

Public Version Number

3

DI Record Publish Date

December 16, 2021

Package DI Number

10850002461098

Quantity per Package

1

Contains DI Package

00850002461091

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON