Catalog Number

202

Brand Name

Geiger TCU 100 Handpiece

Version/Model Number

202

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

-

Product Code

HQO

Product Code Name

Unit, Cautery, Thermal, Ac-Powered

Public Device Record Key

9a7fbadc-3219-469a-b5f3-d939241f8c2e

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

-