Catalog Number

6424

Brand Name

DiaMon Fixation

Version/Model Number

FIx_DiaMon_6424

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

K051085

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Public Device Record Key

8df551a8-600e-4881-9707-23c8c969687e

Public Version Date

December 16, 2020

Public Version Number

1

DI Record Publish Date

December 08, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-