Catalog Number

-

Brand Name

VitreQ

Version/Model Number

CT00.D01

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

K202038,K202038

Product Code

HPS

Product Code Name

Unit, Cryophthalmic

Public Device Record Key

b108f60c-92cc-4f97-8227-60e7f961c16b

Public Version Date

February 09, 2021

Public Version Number

1

DI Record Publish Date

February 01, 2021

Package DI Number

08719214223458

Quantity per Package

3

Contains DI Package

88719214223454

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box