Catalog Number

3269.BE27

Brand Name

27G Chandelier fiber and 23G standard D-style fiber optic handpiece incl. guidan

Version/Model Number

3269.BE27

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

ca258554-6b71-40d2-a1ff-4cecb93f66a6

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

-