Catalog Number

-

Brand Name

Millennium

Version/Model Number

72-52205516

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

HIN

Product Code Name

Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)

Public Device Record Key

3820999c-c901-4f76-ad9d-fcd86019fee0

Public Version Date

November 05, 2019

Public Version Number

1

DI Record Publish Date

October 28, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-