Catalog Number

-

Brand Name

VitreQ

Version/Model Number

LP25.A04

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

HQB

Product Code Name

Photocoagulator And Accessories

Public Device Record Key

2f4f9e35-3b0f-45ca-9985-2a6b2b7da2b4

Public Version Date

August 08, 2022

Public Version Number

1

DI Record Publish Date

July 30, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-