Catalog Number

MBR-000012

Brand Name

Aspirating Biopsy Needle

Version/Model Number

MBR-000012

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"

-

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

K173760,K173760

Product Code

EOQ

Product Code Name

Bronchoscope (Flexible Or Rigid)

Public Device Record Key

c80e8278-ae09-407e-926c-b50f2ad3f281

Public Version Date

July 12, 2019

Public Version Number

2

DI Record Publish Date

June 08, 2018

Package DI Number

B634MBR0000121

Quantity per Package

3

Contains DI Package

B634MBR0000120

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box