Catalog Number

2603063

Brand Name

VESALIUS STERILE single-use tungsten half round loop

Version/Model Number

STERILE, D=0,17mm b=10mm h=10mm L=110mm

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

e7719d21-2363-466c-a4ac-29af5277db60

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

8034055297339

Quantity per Package

5

Contains DI Package

08034055292587

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

DOUBLE ENVELOPE