Catalog Number

-

Brand Name

Tri-Gate Disposable Cannula

Version/Model Number

00-8570

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

GEA

Product Code Name

Cannula, Surgical, General & Plastic Surgery

Public Device Record Key

67367e4c-d245-4a6f-acbf-730a228bcfe0

Public Version Date

May 18, 2022

Public Version Number

1

DI Record Publish Date

May 10, 2022

Package DI Number

10818614020515

Quantity per Package

6

Contains DI Package

00818614020518

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box