Catalog Number

-

Brand Name

Flents

Version/Model Number

K30

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

EWD

Product Code Name

Protector, Hearing (Insert)

Public Device Record Key

d7a6b219-cd43-45e1-8ee1-f77ebeb2ac70

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

October 28, 2020

Package DI Number

20077602000305

Quantity per Package

6

Contains DI Package

00077602000301

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER