Catalog Number

GUS-33-21-019-04

Brand Name

SonoTip Pro Control

Version/Model Number

GUS-33-21-019-04

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

5b4fa3a0-b823-4ce1-8a82-936da830e881

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Package DI Number

4052838014052

Quantity per Package

5

Contains DI Package

04052838014045

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box