Catalog Number

CNM2206-MM

Brand Name

Midwest Medical Inc. (Private Label)

Version/Model Number

CNM2206-MM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K851838,K851838,K851838

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

f7563c5c-9487-467a-9ee7-adc5bb663861

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

20859013006042

Quantity per Package

10

Contains DI Package

10859013006045

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Box