Catalog Number

BMET-8A

Brand Name

BMET-8A

Version/Model Number

8 Gauge x 4"

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

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

K983187,K983187

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

08a2d8eb-7ad0-4c42-837a-479dac47a116

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 08, 2017

Package DI Number

M9797407506M9

Quantity per Package

10

Contains DI Package

M9797407506M0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case