Catalog Number

20132-167

Brand Name

ERBE

Version/Model Number

20132-167

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

K013348,K013348,K013348

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

57010069-9543-40fe-9ef0-42f26cc11fc8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 16, 2016

Package DI Number

04050147015029

Quantity per Package

10

Contains DI Package

04050147020245

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Level: 1