Catalog Number

-

Brand Name

MEDONE

Version/Model Number

MO18200-K0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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"

Yes

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

K172344,K172344

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

f9a57fdd-cfac-4f57-bd2c-a08d4784be13

Public Version Date

February 07, 2020

Public Version Number

1

DI Record Publish Date

January 30, 2020

Package DI Number

18052283958997

Quantity per Package

10

Contains DI Package

08052283958990

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-