Catalog Number

-

Brand Name

FLENTS

Version/Model Number

K1010

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)

-

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

173bc529-9323-4b00-bfc6-f929c15b7df4

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 06, 2016

Package DI Number

20077602010106

Quantity per Package

6

Contains DI Package

00077602010102

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BAG