Catalog Number

20132-250

Brand Name

ERBE

Version/Model Number

20132-250

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

76f6b69b-c238-4d2d-84d3-e40b849e4f0e

Public Version Date

November 08, 2021

Public Version Number

3

DI Record Publish Date

April 24, 2019

Package DI Number

04050147017771

Quantity per Package

5

Contains DI Package

04050147017764

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Level 1