symphonX™ - Device for cutting or coagulating tissue; to be - Fortimedix Surgical B.V.

Duns Number:492888563

Device Description: Device for cutting or coagulating tissue; to be used in combination with an electrosurgica Device for cutting or coagulating tissue; to be used in combination with an electrosurgical generator

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More Product Details

Catalog Number

314-005

Brand Name

symphonX™

Version/Model Number

Hook-knife

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 10, 2020

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Device Record Status

Public Device Record Key

02c3fbaf-b335-4c57-8f4e-cb0bf359888c

Public Version Date

September 14, 2020

Public Version Number

7

DI Record Publish Date

February 15, 2017

Additional Identifiers

Package DI Number

08719324463058

Quantity per Package

6

Contains DI Package

08719324463157

Package Discontinue Date

September 10, 2020

Package Status

Not in Commercial Distribution

Package Type

Carton box

"FORTIMEDIX SURGICAL B.V." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 13