Midway Select - Midway Select Explorer 2 Double End Standard - MIDWAY DENTAL SUPPLY, LLC

Duns Number:102354446

Device Description: Midway Select Explorer 2 Double End Standard Round Handle

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More Product Details

Catalog Number

-

Brand Name

Midway Select

Version/Model Number

002-0649

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)

-

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

EKB

Product Code Name

Explorer, Operative

Device Record Status

Public Device Record Key

2aac0acd-dfd6-42d7-aca8-22b74d589bf6

Public Version Date

March 23, 2022

Public Version Number

1

DI Record Publish Date

March 15, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MIDWAY DENTAL SUPPLY, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 183
2 A medical device with a moderate to high risk that requires special controls. 43