Catalog Number

-

Brand Name

Sonopsy-C1

Version/Model Number

SON2150

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

K013109,K013109

Product Code

FCG

Product Code Name

Biopsy Needle Kit

Public Device Record Key

1c29ff77-37e0-404d-b1f9-b7a5ccbd31ae

Public Version Date

June 03, 2022

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

14526737120048

Quantity per Package

5

Contains DI Package

04526737120041

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-