Catalog Number

-

Brand Name

eCO2

Version/Model Number

eCO2 PLUS(USA) body

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

-

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

7615e660-9072-48ce-b8d0-0c05e235969c

Public Version Date

July 26, 2021

Public Version Number

5

DI Record Publish Date

September 09, 2016

Package DI Number

8809447651590

Quantity per Package

1

Contains DI Package

08809447651583

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton case