Catalog Number

370-1580-02

Brand Name

BioPince™ Ultra Full Core Biopsy Instrument

Version/Model Number

370-1580-02

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

K904987,K904987

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

5cc9a4a4-77f5-4dba-9508-e27f8b063160

Public Version Date

June 24, 2021

Public Version Number

1

DI Record Publish Date

June 16, 2021

Package DI Number

20886333224085

Quantity per Package

5

Contains DI Package

00886333224081

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box