Catalog Number

-

Brand Name

Trocar for Virtuosaph Endoscopied Vein Harvesting System

Version/Model Number

MCTRC550S

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

K083194,K083194

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

95a95b6b-1c2b-4b0f-be72-5e6a054e2873

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

October 11, 2016

Package DI Number

50699753019022

Quantity per Package

10

Contains DI Package

00699753019027

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

10 Piece Case