Catalog Number

-

Brand Name

CAREONE

Version/Model Number

68737CO1

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LRX

Product Code Name

Case, Contact Lens

Public Device Record Key

60e4a6a3-2fa2-418e-bc03-4497615c814a

Public Version Date

July 04, 2022

Public Version Number

1

DI Record Publish Date

June 24, 2022

Package DI Number

20023185000386

Quantity per Package

6

Contains DI Package

00041520039293

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER