Catalog Number

701116060M

Brand Name

SuperCore™ Biopsy Instrument

Version/Model Number

701116060M

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

-

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

bfa79f4d-155e-4750-8c44-ee3d511f2b14

Public Version Date

June 24, 2021

Public Version Number

1

DI Record Publish Date

June 16, 2021

Package DI Number

20886333225655

Quantity per Package

10

Contains DI Package

00886333225651

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box