Catalog Number

001-138

Brand Name

ClikRay Size 1 Sensor Cover 34mm/ 500 box

Version/Model Number

001-138

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KQM

Product Code Name

Camera, Surgical And Accessories

Public Device Record Key

c99346b7-3567-40bb-ba71-3b5162d8e1bc

Public Version Date

January 08, 2021

Public Version Number

1

DI Record Publish Date

December 31, 2020

Package DI Number

10856200001135

Quantity per Package

20

Contains DI Package

00856200001138

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE