Catalog Number

BIPDDSC

Brand Name

Dornier MedTech

Version/Model Number

Bipolar Dornier Disc ™ For Vaporization 24 Fr. Electrode-Sterile, Single-Use. (6

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FAS

Product Code Name

Electrode, Electrosurgical, Active, Urological

Public Device Record Key

d2c70e27-946f-42b4-8398-6480077e78b1

Public Version Date

June 29, 2020

Public Version Number

1

DI Record Publish Date

June 19, 2020

Package DI Number

00810116021772

Quantity per Package

6

Contains DI Package

00810116021703

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box