Catalog Number

314-006

Brand Name

symphonX™

Version/Model Number

Suction/Irrigation

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 10, 2020

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

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

d9388e8f-f7cf-47a8-97df-064efb295418

Public Version Date

September 14, 2020

Public Version Number

8

DI Record Publish Date

February 15, 2017

Package DI Number

08719324463065

Quantity per Package

6

Contains DI Package

08719324463164

Package Discontinue Date

September 10, 2020

Package Status

Not in Commercial Distribution

Package Type

Carton box