Catalog Number

7006001

Brand Name

Clement Clarke Ophthalmic

Version/Model Number

7006001

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HLE

Product Code Name

Ruler, Nearpoint (Punctometer)

Public Device Record Key

aa02e6ee-27f9-4c80-8ef9-bf0c288b00c6

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 05, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-