Catalog Number

601001000

Brand Name

aScope™ 4 Cysto

Version/Model Number

601001000

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"

-

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

FAJ

Product Code Name

Cystoscope and accessories, flexible/rigid

Public Device Record Key

f8bb0ae2-165a-4444-81e4-45556e94b94a

Public Version Date

January 21, 2021

Public Version Number

2

DI Record Publish Date

May 20, 2020

Package DI Number

05707480140602

Quantity per Package

4

Contains DI Package

05707480140596

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-