Catalog Number

-

Brand Name

Qora Aeon Stool Management Kit

Version/Model Number

MG-12015-002

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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"

Yes

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

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

9198ec24-f6c7-499e-bfcb-962fcaed777a

Public Version Date

January 04, 2021

Public Version Number

4

DI Record Publish Date

November 23, 2017

Package DI Number

10860974000348

Quantity per Package

10

Contains DI Package

00860974000341

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

10 Device Boxes