Catalog Number

-

Brand Name

Centurion

Version/Model Number

LENSHOLDST

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"

Yes

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

K030987,K030987

Product Code

LRX

Product Code Name

CASE, CONTACT LENS

Public Device Record Key

ae2db61a-8184-4ce8-b223-8b9872c76574

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 14, 2016

Package DI Number

00653160286793

Quantity per Package

50

Contains DI Package

10653160286790

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE