Midway Select - Sterilization Pouch 2 1/4" x 4" Pkg/200 - MIDWAY DENTAL SUPPLY, LLC

Duns Number:102354446

Device Description: Sterilization Pouch 2 1/4" x 4" Pkg/200

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More Product Details

Catalog Number

-

Brand Name

Midway Select

Version/Model Number

002-0035

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

Yes

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

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Device Record Status

Public Device Record Key

8def577f-0341-48f7-abd7-88e57cf40064

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

November 19, 2018

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