Catalog Number

20080

Brand Name

LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy)

Version/Model Number

LUMBx-360 UP

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

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

K210512,K210512,K210512

Product Code

FAJ

Product Code Name

Cystoscope And Accessories, Flexible/Rigid

Public Device Record Key

6a1cd7d9-d09a-4f8d-836b-f3a05a913c9f

Public Version Date

August 23, 2021

Public Version Number

1

DI Record Publish Date

August 13, 2021

Package DI Number

10853277008081

Quantity per Package

5

Contains DI Package

00853277008084

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pouch