Catalog Number

PCVINT3

Brand Name

PERCUVANCE

Version/Model Number

IPN027872

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

K153063,K153063,K153063

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Public Device Record Key

1050b026-3d61-4e31-889f-fd7ba18fd959

Public Version Date

June 16, 2021

Public Version Number

11

DI Record Publish Date

November 16, 2017

Package DI Number

34026704582830

Quantity per Package

6

Contains DI Package

24026704582833

Package Discontinue Date

June 15, 2021

Package Status

Not in Commercial Distribution

Package Type

Box