Catalog Number

-

Brand Name

NEC

Version/Model Number

MD322C8

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 08, 2017

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

-

Product Code

PGY

Product Code Name

Display, Diagnostic Radiology

Public Device Record Key

ac7cb024-178e-4e20-8d63-6a92e8351a86

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

September 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-