Catalog Number

-

Brand Name

System TBI STEP 2,4m

Version/Model Number

P10107-757

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K081218

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

9964ad8a-d758-4662-97c6-6720382980e5

Public Version Date

May 18, 2022

Public Version Number

1

DI Record Publish Date

May 10, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-