Catalog Number

-

Brand Name

BIOPSY NEEDLE

Version/Model Number

RP1000-1820

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

72f5a4fb-9555-4a41-ab55-62b017b9756f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 22, 2015

Package DI Number

10812444022305

Quantity per Package

10

Contains DI Package

00812444022308

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-