Catalog Number

314-010

Brand Name

symphonX™

Version/Model Number

Clip Applier short

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

d0f261e5-9847-4996-98bb-266d532f5c81

Public Version Date

August 24, 2021

Public Version Number

9

DI Record Publish Date

August 25, 2017

Package DI Number

08719324463249

Quantity per Package

6

Contains DI Package

08719324463348

Package Discontinue Date

September 10, 2020

Package Status

Not in Commercial Distribution

Package Type

Carton box