Catalog Number

483001000US

Brand Name

aScope™ Gastro

Version/Model Number

483001000US

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

FDS

Product Code Name

Gastroscope and accessories, flexible/rigid

Public Device Record Key

f3c66a12-4d59-4a97-93fd-88fcfa61b287

Public Version Date

April 25, 2022

Public Version Number

1

DI Record Publish Date

April 16, 2022

Package DI Number

05707480148165

Quantity per Package

6

Contains DI Package

05707480148172

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-