Catalog Number

482001000

Brand Name

aScope™ Duodeno

Version/Model Number

482001000

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

K201098,K201098

Product Code

FDT

Product Code Name

Duodenoscope and accessories, flexible/rigid

Public Device Record Key

b657fef4-8db6-48d7-b6b6-6b90cf35ffc2

Public Version Date

August 18, 2020

Public Version Number

1

DI Record Publish Date

August 10, 2020

Package DI Number

05707480145270

Quantity per Package

6

Contains DI Package

05707480145287

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-