Catalog Number

-

Brand Name

DualCore Biopsy System-16g x 10cm

Version/Model Number

MCN1610

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K973565

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

67243530-67d8-44e1-89e8-dfa040514e3d

Public Version Date

May 30, 2022

Public Version Number

1

DI Record Publish Date

May 20, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-