Catalog Number

-

Brand Name

MocareHealth

Version/Model Number

7235M

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

b9a2e2ab-bcdd-482a-9e23-982daa92b867

Public Version Date

September 01, 2021

Public Version Number

1

DI Record Publish Date

August 24, 2021

Package DI Number

36971384150030

Quantity per Package

10

Contains DI Package

26971384150033

Package Discontinue Date

August 24, 2021

Package Status

Not in Commercial Distribution

Package Type

CASE