Catalog Number

-

Brand Name

BIOPSY NEEDLE

Version/Model Number

RPM1000-1820

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

K092059,K092059

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

ffd401fd-975d-4702-bf39-90c9fe442496

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 22, 2015

Package DI Number

10812444022954

Quantity per Package

10

Contains DI Package

00812444022957

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-