Catalog Number

3269.D04

Brand Name

Endoillumination Probe, including illuminated scleral depressor. (27 gauge / 0.4

Version/Model Number

3269.D04

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K062895,K062895

Product Code

MPA

Product Code Name

Endoilluminator

Public Device Record Key

a120dc5e-f5fc-4f6c-b186-8972e53ceea4

Public Version Date

May 07, 2019

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-