Catalog Number

-

Brand Name

VitreQ

Version/Model Number

LF00.R05

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

-

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

FFY

Product Code Name

Adaptor, Bulbs, Miscellaneous, For Endoscope

Public Device Record Key

6419185c-e7bf-428e-9a11-db73b819d4b8

Public Version Date

September 28, 2022

Public Version Number

2

DI Record Publish Date

May 12, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-