Catalog Number

-

Brand Name

Acculite EndoOcular

Version/Model Number

Illum/Sm Plug, 20ga str, SMA 906, 200µm

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 21, 2020

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

-

Product Code

HQF

Product Code Name

Laser, Ophthalmic

Public Device Record Key

81d0a691-4b33-41a8-b828-18baacd8ce68

Public Version Date

February 24, 2020

Public Version Number

4

DI Record Publish Date

September 25, 2016

Package DI Number

17290109140787

Quantity per Package

10

Contains DI Package

07290109140780

Package Discontinue Date

February 21, 2020

Package Status

Not in Commercial Distribution

Package Type

-