Catalog Number

-

Brand Name

INFINI

Version/Model Number

16 pin Tip (Optional) 1 ea

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

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Public Device Record Key

7fabbf81-597a-45b6-bb90-50458afb3c81

Public Version Date

July 26, 2021

Public Version Number

2

DI Record Publish Date

January 15, 2019

Package DI Number

08809447652382

Quantity per Package

10

Contains DI Package

08809447652399

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tyvek pouch