Catalog Number

-

Brand Name

ERBE

Version/Model Number

20191-378

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

c1526268-ad99-4cfc-a1c4-3dacce2ff984

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

December 12, 2017

Package DI Number

36939029815850

Quantity per Package

4

Contains DI Package

26939029815853

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton Box