Catalog Number

-

Brand Name

Duette™

Version/Model Number

D-10018

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K941488,K941488

Product Code

EZL

Product Code Name

CATHETER, RETENTION TYPE, BALLOON

Public Device Record Key

bf6eafdd-6afc-4198-8e5b-e948093a733d

Public Version Date

December 04, 2020

Public Version Number

9

DI Record Publish Date

January 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-