Catalog Number

I 1510M

Brand Name

BMN I TYPE

Version/Model Number

BMN I TYPE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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"

Yes

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

K020987,K020987

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

a7b9c3f0-7a2b-400e-84e4-6423df6a302c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 26, 2016

Package DI Number

38033003343518

Quantity per Package

10

Contains DI Package

08033003343517

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-