CONTROL UNIT, VETPRO DC - Midmark Intra-Oral X-ray system - MIDMARK CORPORATION

Duns Number:005036025

Device Description: Midmark Intra-Oral X-ray system

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More Product Details

Catalog Number

30-A1041

Brand Name

CONTROL UNIT, VETPRO DC

Version/Model Number

30-A1041

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

-

Product Code Details

Product Code

EHD

Product Code Name

Unit, X-Ray, Extraoral With Timer

Device Record Status

Public Device Record Key

d7735a4a-e4db-47df-8b7f-3443e77f94bd

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 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