Catalog Number

-

Brand Name

Acuity

Version/Model Number

18

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2020

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K163254

Product Code

HQD

Product Code Name

Lens, Contact (Other Material) - Daily

Public Device Record Key

a6253e84-bd25-49a9-b02e-df954ce56cb7

Public Version Date

December 31, 2020

Public Version Number

4

DI Record Publish Date

September 28, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-