Ritter M3 UltraFast - The M3 UltraFast can be used in medical and - MIDMARK CORPORATION

Duns Number:005036025

Device Description: The M3 UltraFast can be used in medical and dental offices, hospitals, clinics, nursing ho The M3 UltraFast can be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization.

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More Product Details

Catalog Number

M3-003

Brand Name

Ritter M3 UltraFast

Version/Model Number

M3-003

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

K090670

Product Code Details

Product Code

FLE

Product Code Name

Sterilizer, Steam

Device Record Status

Public Device Record Key

c3403a31-dc90-4802-9c53-519068245593

Public Version Date

July 06, 2018

Public Version Number

3

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