Catalog Number

20020

Brand Name

LUMINELLE DTx 360 Rotatable Disposable Sheaths

Version/Model Number

LUMDTx-360

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"

Yes

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

K181909,K181909

Product Code

FAJ

Product Code Name

Cystoscope And Accessories, Flexible/Rigid

Public Device Record Key

811a70f7-2252-4b0f-b46e-8cc2c3b81a9a

Public Version Date

November 05, 2019

Public Version Number

2

DI Record Publish Date

May 30, 2019

Package DI Number

10853277008005

Quantity per Package

1

Contains DI Package

00853277008008

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pouch