Midmark - Records and prints sterilization cycle data - MIDMARK CORPORATION

Duns Number:005036025

Device Description: Records and prints sterilization cycle data including time, chamber temperature, and press Records and prints sterilization cycle data including time, chamber temperature, and pressure

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More Product Details

Catalog Number

9A599001

Brand Name

Midmark

Version/Model Number

9A599001

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K163337

Product Code Details

Product Code

FLE

Product Code Name

Sterilizer, steam

Device Record Status

Public Device Record Key

37bba2ce-f9e2-45df-a142-7d32b507e304

Public Version Date

August 09, 2019

Public Version Number

1

DI Record Publish Date

August 01, 2019

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