Catalog Number

601005000

Brand Name

aScope™ 4 Cysto

Version/Model Number

601005000

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

399c50fd-b9bf-4298-b847-d43d097baaf3

Public Version Date

May 25, 2021

Public Version Number

1

DI Record Publish Date

May 17, 2021

Package DI Number

05707480146338

Quantity per Package

5

Contains DI Package

05707480146345

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-