Catalog Number

-

Brand Name

TopCare Health

Version/Model Number

68000TC1

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

9f6f8735-24c6-4239-af0b-c0f3039df189

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

August 10, 2020

Package DI Number

20023185002489

Quantity per Package

6

Contains DI Package

00036800354074

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag