Catalog Number

V8201

Brand Name

Midmark Extraoral Imaging System (EOIS)

Version/Model Number

60-A0012 / 60-A0016

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

K201667

Product Code

MUH

Product Code Name

System, x-ray, extraoral source, digital

Public Device Record Key

9e7a8323-3280-47c8-83f0-c7c64479e287

Public Version Date

December 29, 2020

Public Version Number

1

DI Record Publish Date

December 21, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-