Catalog Number

EHYNF

Brand Name

Green RE 400 Speed

Version/Model Number

Green RE 400 Speed 10X12

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

K023020

Product Code

IXA

Product Code Name

Cassette, radiographic film

Public Device Record Key

93fbe68b-f9b3-42de-9684-849b6a5d0a94

Public Version Date

June 14, 2019

Public Version Number

4

DI Record Publish Date

September 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-