Catalog Number

2605019

Brand Name

VESALIUS STERILE single-use stainless steel sword blade electrode

Version/Model Number

STERILE, L=25mm 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

ef6f62f7-fbad-40f0-bb91-4dd7fff73850

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

December 31, 2017

Package DI Number

08034055293034

Quantity per Package

10

Contains DI Package

08034055296820

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-