Catalog Number

-

Brand Name

Retia Medical

Version/Model Number

FG-007

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

K181372

Product Code

DXG

Product Code Name

Computer, Diagnostic, Pre-Programmed, Single-Function

Public Device Record Key

299e30ca-988a-48ad-a0e5-2daed45fb414

Public Version Date

April 20, 2020

Public Version Number

1

DI Record Publish Date

April 10, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-