Catalog Number

148082st

Brand Name

GATEWAY™ SILICONE CANNULA, 8.0mm X 20mm

Version/Model Number

3910-080-020

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GEA

Product Code Name

Cannula, Surgical, General & Plastic Surgery

Public Device Record Key

ec61d447-0ab5-4a27-801a-82a2bd77cd16

Public Version Date

February 16, 2022

Public Version Number

1

DI Record Publish Date

February 08, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-