symphonX™ - The symphonX™ Handle with ratchet is for use in - Fortimedix Surgical B.V.

Duns Number:492888563

Device Description: The symphonX™ Handle with ratchet is for use in combination with the symphonX™ Instruments The symphonX™ Handle with ratchet is for use in combination with the symphonX™ Instruments of the types: Grasper (short), Maryland (short), Scissors (short) and Clip Applier (short).

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More Product Details

Catalog Number

314-302

Brand Name

symphonX™

Version/Model Number

Handle with ratchet

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

-

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

38665386-32c1-4a19-8f27-c1bae5a7eee0

Public Version Date

September 14, 2020

Public Version Number

5

DI Record Publish Date

November 28, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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