Catalog Number

-

Brand Name

Flents

Version/Model Number

68354/68354CA

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

LXQ

Product Code Name

Cup, Eye

Public Device Record Key

47cd71c5-8771-459a-b597-426de21a2074

Public Version Date

September 29, 2020

Public Version Number

1

DI Record Publish Date

September 21, 2020

Package DI Number

20025715683540

Quantity per Package

6

Contains DI Package

00025715683546

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER