Catalog Number

-

Brand Name

Acculite™ EndoOcular®

Version/Model Number

Aspirating, 20ga str, SMA 906, 200µm

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 28, 2019

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

HJM

Product Code Name

Transilluminator, Ac-Powered

Public Device Record Key

467a0916-c3a2-4573-9d2d-9375b64b3183

Public Version Date

August 29, 2019

Public Version Number

4

DI Record Publish Date

September 25, 2016

Package DI Number

17290109140763

Quantity per Package

10

Contains DI Package

07290109140766

Package Discontinue Date

August 28, 2019

Package Status

Not in Commercial Distribution

Package Type

-