Catalog Number

-

Brand Name

NA

Version/Model Number

B5A9305

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 06, 2020

Issuing Agency

In HIBCC

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"

Yes

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

K050807,K050807

Product Code

HQF

Product Code Name

Laser, Ophthalmic

Public Device Record Key

440930d9-0f3c-4c25-8c58-b9222e98332c

Public Version Date

July 28, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

M735B5A93055

Quantity per Package

10

Contains DI Package

M735B5A93051

Package Discontinue Date

June 11, 2020

Package Status

Not in Commercial Distribution

Package Type

-