Catalog Number

7-101-12CS

Brand Name

ELECTROASE

Version/Model Number

7-101-12CS

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

-

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

33d35f21-6b93-44a9-b9d4-c68577918701

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

20653405031663

Quantity per Package

1200

Contains DI Package

10653405031666

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE