Catalog Number

600177000

Brand Name

aScope™ 4 Cysto

Version/Model Number

600177000

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

fe558ae8-ca0e-44fd-a87d-e979ef9f1aa9

Public Version Date

September 29, 2022

Public Version Number

1

DI Record Publish Date

September 21, 2022

Package DI Number

05707480157945

Quantity per Package

4

Contains DI Package

05707480157938

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-