Catalog Number

-

Brand Name

NA

Version/Model Number

B625213

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

b86b27aa-ad82-43aa-8926-1f2c311ff554

Public Version Date

July 28, 2022

Public Version Number

5

DI Record Publish Date

February 09, 2018

Package DI Number

M735B6252135

Quantity per Package

10

Contains DI Package

M735B6252131

Package Discontinue Date

June 11, 2020

Package Status

Not in Commercial Distribution

Package Type

-