Catalog Number

P10106-322

Brand Name

Fraxion

Version/Model Number

P10106-322

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

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

K112210,K112210

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

f1065c62-fb37-467e-8a7c-03a5195194c1

Public Version Date

October 13, 2021

Public Version Number

5

DI Record Publish Date

August 23, 2016

Package DI Number

04056719001605

Quantity per Package

10

Contains DI Package

04056719001773

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-