Catalog Number

-

Brand Name

TopCare Health

Version/Model Number

K30TC1

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

1f77aa30-3d84-4170-b633-6b9548884998

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

August 10, 2020

Package DI Number

20036800296606

Quantity per Package

6

Contains DI Package

00036800296602

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box