Midmark - Midmark Procenter LR Concept (Midmark Elevance - MIDMARK CORPORATION

Duns Number:005036025

Device Description: Midmark Procenter LR Concept (Midmark Elevance Chairs) Cuspidor and Assistant's Combinatio

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More Product Details

Catalog Number

153604LRCA-E

Brand Name

Midmark

Version/Model Number

153604LRCA-E

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

K003090

Product Code Details

Product Code

EIA

Product Code Name

Unit, operative dental

Device Record Status

Public Device Record Key

33eac54b-e058-4c5e-b6be-58e7817d0554

Public Version Date

June 01, 2020

Public Version Number

1

DI Record Publish Date

May 22, 2020

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