Catalog Number

BA149

Brand Name

ACHIEVE

Version/Model Number

BA149

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

902498ac-4a13-47c6-9b96-bc4417b27bd3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 08, 2017

Package DI Number

50885403238053

Quantity per Package

5

Contains DI Package

10885403238055

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case