Catalog Number

G2N99412

Brand Name

GEN2

Version/Model Number

G2N99412

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

-

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

JOL

Product Code Name

Catheter And Tip, Suction

Public Device Record Key

26cf3c3a-bd61-4d69-ab6b-2f0e8a4e826e

Public Version Date

November 01, 2022

Public Version Number

1

DI Record Publish Date

October 24, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-