Virtuosaph Plus Endoscopic Vessel Harvester - Terumo Cardiovascular Systems Corporation

Duns Number:177655466

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More Product Details

Catalog Number

-

Brand Name

Virtuosaph Plus Endoscopic Vessel Harvester

Version/Model Number

VSP550

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K160206,K160206

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

c15dac26-49a8-4bbd-b64f-96e2466109af

Public Version Date

February 07, 2019

Public Version Number

5

DI Record Publish Date

October 12, 2016

Additional Identifiers

Package DI Number

50699753022961

Quantity per Package

5

Contains DI Package

00699753022966

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

5 Piece Case

"TERUMO CARDIOVASCULAR SYSTEMS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 36
2 A medical device with a moderate to high risk that requires special controls. 174