Catalog Number

410.030.007

Brand Name

GALILEI

Version/Model Number

G6

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

K182659

Product Code

MXK

Product Code Name

Device, Analysis, Anterior Segment

Public Device Record Key

f52a5a82-27db-4816-9e81-3a892ba413ea

Public Version Date

September 30, 2019

Public Version Number

1

DI Record Publish Date

September 20, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-