Catalog Number

-

Brand Name

Acculite EndoOcular

Version/Model Number

Standard, 20ga str taper, SmartScan, 200µm

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 20, 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

K812219,K812219

Product Code

HQF

Product Code Name

Laser, Ophthalmic

Public Device Record Key

864e8a5b-e8fb-452c-914c-a6bbe3bf67b1

Public Version Date

May 21, 2019

Public Version Number

4

DI Record Publish Date

September 26, 2016

Package DI Number

17290109142781

Quantity per Package

10

Contains DI Package

07290109142784

Package Discontinue Date

May 20, 2019

Package Status

Not in Commercial Distribution

Package Type

-