Catalog Number

150

Brand Name

Geiger Thermal Cautery Unit

Version/Model Number

150

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

-

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

K002341

Product Code

HQO

Product Code Name

Unit, Cautery, Thermal, Ac-Powered

Public Device Record Key

3b41f459-e6e6-4305-b682-1b85ba0e68b1

Public Version Date

August 10, 2018

Public Version Number

1

DI Record Publish Date

July 10, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-