Catalog Number

30-6220

Brand Name

CORLO Twoomey

Version/Model Number

30-6220

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

KNT

Product Code Name

TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Public Device Record Key

821174b1-be1c-4582-83f7-c3ec6f598417

Public Version Date

October 07, 2019

Public Version Number

3

DI Record Publish Date

August 04, 2016

Package DI Number

20815149024183

Quantity per Package

5

Contains DI Package

10815149024186

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-