Catalog Number

20150-215

Brand Name

ERBE

Version/Model Number

20150-215

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

K143306,K143306

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

9845844e-8a17-4179-8c72-eba6898c2c00

Public Version Date

February 06, 2020

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

04050147020108

Quantity per Package

5

Contains DI Package

04050147020092

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Level: 1