Catalog Number

20190-166

Brand Name

ERBE

Version/Model Number

20190-166

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

K092732,K092732,K092732

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

6f21d49a-7f7e-4349-82d0-84bc9b96b6ce

Public Version Date

March 18, 2019

Public Version Number

1

DI Record Publish Date

March 08, 2019

Package DI Number

28809083941745

Quantity per Package

2

Contains DI Package

18809083941748

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton Box