Midmark ClearVision Digital Sensor System - Intraoral X-ray with Digital Imaging Sensor - MIDMARK CORPORATION

Duns Number:005036025

Device Description: Intraoral X-ray with Digital Imaging Sensor

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More Product Details

Catalog Number

XSDS-0B

Brand Name

Midmark ClearVision Digital Sensor System

Version/Model Number

XSDS-0B

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K112380

Product Code Details

Product Code

MUH

Product Code Name

System,X-Ray,Extraoral Source,Digital

Device Record Status

Public Device Record Key

85ab6e25-e192-45fc-8df1-ee7a4f516627

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MIDMARK CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 838
2 A medical device with a moderate to high risk that requires special controls. 544