Catalog Number

20882-01

Brand Name

Exactrac

Version/Model Number

6.2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 09, 2022

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K120789

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

b5471ae7-25bd-4301-9324-93848f0cc884

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

September 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-