Catalog Number

PCVSHL3

Brand Name

PERCUVANCE

Version/Model Number

IPN028439

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 15, 2021

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

K181852,K181852,K181852,K181852

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Public Device Record Key

e0ef7e31-1880-4f3f-9342-d5f01b2b0955

Public Version Date

June 16, 2021

Public Version Number

5

DI Record Publish Date

October 22, 2018

Package DI Number

34026704640240

Quantity per Package

6

Contains DI Package

14026704640246

Package Discontinue Date

June 15, 2021

Package Status

Not in Commercial Distribution

Package Type

Box