Catalog Number

-

Brand Name

Virtuosaph Havester - Japan Only

Version/Model Number

MCVS550HVJ

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

24efe9a7-8055-411f-a993-604269eee262

Public Version Date

February 07, 2019

Public Version Number

5

DI Record Publish Date

October 11, 2016

Package DI Number

50699753021070

Quantity per Package

55

Contains DI Package

00699753021075

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

5 Piece Case