Catalog Number

-

Brand Name

CONSTELLATION® ULTRAVIT® ENGAUGE®

Version/Model Number

8065751700

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"

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

-

Product Code

HQE

Product Code Name

Instrument, vitreous aspiration and cutting, ac-powered

Public Device Record Key

ed20c023-c7aa-47e2-a641-f2adac865160

Public Version Date

January 24, 2020

Public Version Number

1

DI Record Publish Date

January 16, 2020

Package DI Number

10380657517005

Quantity per Package

6

Contains DI Package

00380657517008

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-