Catalog Number

20060

Brand Name

LUMINELLE DTx 360 Rigid Rotatable Disposable Sheath

Version/Model Number

LUMDTx-360R

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

K190827,K190827

Product Code

FAJ

Product Code Name

Cystoscope And Accessories, Flexible/Rigid

Public Device Record Key

c41b9a24-bdf3-4d20-9979-58bfe61945d0

Public Version Date

November 05, 2019

Public Version Number

2

DI Record Publish Date

June 17, 2019

Package DI Number

10853277008050

Quantity per Package

5

Contains DI Package

00853277008053

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pouch