Catalog Number

I 1807M

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

61c19b89-5673-4634-a21f-e81324fc45b7

Public Version Date

December 26, 2019

Public Version Number

1

DI Record Publish Date

December 18, 2019

Package DI Number

38033003343549

Quantity per Package

10

Contains DI Package

08033003343548

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-