Catalog Number

-

Brand Name

CLARITY II

Version/Model Number

CLARITY II ICD CAN ASSY 360g

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

b715ad59-0437-45dc-9706-781fdffe791b

Public Version Date

July 26, 2021

Public Version Number

2

DI Record Publish Date

June 17, 2020

Package DI Number

08809447652719

Quantity per Package

12

Contains DI Package

08809447652702

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX