Catalog Number

54013

Brand Name

Contact Lens, HD Professional, Cohen-Benner, "CBC"

Version/Model Number

54013

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

K051630,K051630

Product Code

HJK

Product Code Name

Lens, Contact, Polymethylmethacrylate, Diagnostic

Public Device Record Key

258d8ed9-0a8e-40db-9d03-0a0aa0e89799

Public Version Date

June 02, 2021

Public Version Number

3

DI Record Publish Date

February 26, 2021

Package DI Number

10852475007209

Quantity per Package

10

Contains DI Package

00852475007202

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case