Catalog Number

-

Brand Name

Bone marrow biopsy system

Version/Model Number

BOW-1066-08-0100

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

8a5c0a0f-88d3-4df1-90de-77c4a58caca7

Public Version Date

February 07, 2022

Public Version Number

3

DI Record Publish Date

August 18, 2021

Package DI Number

04260632793299

Quantity per Package

10

Contains DI Package

04260632793213

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-