Catalog Number

A189/B

Brand Name

Achieve®

Version/Model Number

10884450443962

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

-

Product Code

KNW

Product Code Name

INSTRUMENT, BIOPSY

Public Device Record Key

11933677-0ea5-4187-870c-1fba48f0c326

Public Version Date

October 11, 2021

Public Version Number

2

DI Record Publish Date

March 23, 2020

Package DI Number

20884450443969

Quantity per Package

12

Contains DI Package

10884450443962

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-