Catalog Number

-

Brand Name

TopCare

Version/Model Number

XES

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EAX

Product Code Name

Mirror, Mouth

Public Device Record Key

d18f1aaa-ad5e-4af2-bd45-35ba26e184f1

Public Version Date

January 08, 2021

Public Version Number

2

DI Record Publish Date

June 24, 2020

Package DI Number

10036800442242

Quantity per Package

72

Contains DI Package

00036800442245

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case