StopCon-Cap Olympus® Cap with Air/Water tubing for Olympus® - GA Health Company Limited

Duns Number:686908512

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

StopCon-Cap Olympus® Cap with Air/Water tubing for Olympus®

Version/Model Number

EN10901B

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

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 Details

Product Code

OCX

Product Code Name

Endoscopic Irrigation/Suction System

Device Record Status

Public Device Record Key

c37e6291-03fd-4d79-a4f0-56dad41a9cfc

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

January 31, 2022

Additional Identifiers

Package DI Number

14897106952257

Quantity per Package

10

Contains DI Package

04897106952250

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"GA HEALTH COMPANY LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8
2 A medical device with a moderate to high risk that requires special controls. 3