Catalog Number

-

Brand Name

Rezūm Accessory Kit

Version/Model Number

D2202

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 24, 2018

Issuing Agency

In GS1

MRI safety Status

MR Safe

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"

Yes

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

75af2d7c-dfb4-4475-8e79-d388cd4fc994

Public Version Date

November 22, 2018

Public Version Number

5

DI Record Publish Date

July 17, 2017

Package DI Number

00855357006041

Quantity per Package

5

Contains DI Package

00855357006034

Package Discontinue Date

October 24, 2018

Package Status

Not in Commercial Distribution

Package Type

Box