Catalog Number

-

Brand Name

MocareHealth

Version/Model Number

7235XS

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"

Yes

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

K030207,K030207

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

052b94fa-e05c-4532-a2e2-28dba5ec376d

Public Version Date

September 17, 2020

Public Version Number

1

DI Record Publish Date

September 09, 2020

Package DI Number

36971384150016

Quantity per Package

10

Contains DI Package

26971384150019

Package Discontinue Date

September 09, 2025

Package Status

In Commercial Distribution

Package Type

CASE