Catalog Number

ITG-31620

Brand Name

Sovea™

Version/Model Number

ITG-31620

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"

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

K092418,K092418,K092418

Product Code

KNT

Product Code Name

Tubes, Gastrointestinal (And Accessories)

Public Device Record Key

7a8beceb-b495-4974-bcbe-4c54895a5747

Public Version Date

May 11, 2020

Public Version Number

3

DI Record Publish Date

February 10, 2020

Package DI Number

50850009501221

Quantity per Package

6

Contains DI Package

30850009501227

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton