Catalog Number

-

Brand Name

2.5mm Extended Retinal Pencil

Version/Model Number

2509-P-8001

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K062412

Product Code

HRN

Product Code Name

Unit, Cryophthalmic, Ac-Powered

Public Device Record Key

d9064c36-44f1-4be1-b0ba-79e9d402f309

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-