Catalog Number

-

Brand Name

Huestis Medical Flexi-Holder

Version/Model Number

FH410

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K792721

Product Code

IXA

Product Code Name

Cassette, Radiographic Film

Public Device Record Key

8a5a558f-041d-4aaa-bebe-54c96c09893c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-