Catalog Number

2602059

Brand Name

VESALIUS STERILE single-use GLADIO wire electrode for microsurgery

Version/Model Number

STERILE, lf=3mm L=100mm GLADIO

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"

Yes

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

-

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

4dfdcdb4-f504-470a-87fa-8d8d715a9037

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

8034055298091

Quantity per Package

10

Contains DI Package

08034055297933

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

double envelope