Catalog Number

-

Brand Name

INFINI

Version/Model Number

49 pin Tip (Standard) 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

6ba8125a-399b-4577-b858-f1510eb03281

Public Version Date

July 26, 2021

Public Version Number

2

DI Record Publish Date

January 15, 2019

Package DI Number

08809447652368

Quantity per Package

10

Contains DI Package

08809447652375

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Tyvek pouch