Catalog Number

-

Brand Name

Erbe

Version/Model Number

20190-107U

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

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

3f2a7d85-605e-485e-bc0c-3bd68e90d97b

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

September 06, 2017

Package DI Number

26939029815020

Quantity per Package

30

Contains DI Package

06939029815026

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

inner box