Catalog Number

TM31013

Brand Name

NA

Version/Model Number

Semiflex 0.3 cm³ ion chamber

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K972212

Product Code

LHN

Product Code Name

System, Radiation Therapy, Charged-Particle, Medical

Public Device Record Key

668ff849-0d57-4d41-99b5-324806c098aa

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-