Catalog Number

-

Brand Name

ACUVUE Abiliti overnight for myopia management with astigmatism

Version/Model Number

ACUVUE Abiliti

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NUU

Product Code Name

Lens, Contact, Orthokeratology, Overnight

Public Device Record Key

87d8c7ab-ce8a-41f7-8ed8-ae7cddb7bffa

Public Version Date

February 02, 2022

Public Version Number

1

DI Record Publish Date

January 25, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-