Catalog Number

040153

Brand Name

Carbon Bright ®

Version/Model Number

040153

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

fb7799d8-283e-4c47-ac7e-de8f41067650

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

February 18, 2020

Package DI Number

10850002461067

Quantity per Package

10

Contains DI Package

00850002461060

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton