Catalog Number

-

Brand Name

iProElite

Version/Model Number

iProElite

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

K212478

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

e8cbd8e5-f00a-4fc0-bb3b-6fd1bc2970b6

Public Version Date

July 18, 2022

Public Version Number

1

DI Record Publish Date

July 09, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-