Catalog Number

GUS-21-18-022

Brand Name

SonoTip II EBUS

Version/Model Number

GUS-21-18-022

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

FCG

Product Code Name

Biopsy Needle

Public Device Record Key

475ed67e-c578-4ce3-815c-50758a26224f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 31, 2017

Package DI Number

04052838011082

Quantity per Package

5

Contains DI Package

04052838011099

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box