Catalog Number

Boston XO2

Brand Name

Boston XO2

Version/Model Number

hexafocon B

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

HQD

Product Code Name

Lens, Contact (Other Material) - Daily

Public Device Record Key

30d72a08-8419-4a4c-8f59-092be5042b81

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 24, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-