Catalog Number

-

Brand Name

MocareHealth

Version/Model Number

1610ST80

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K063757,K063757,K063757

Product Code

KGO

Product Code Name

Surgeon'S Gloves

Public Device Record Key

afd3c1ab-3038-4834-9a25-3c09bd2c269c

Public Version Date

April 22, 2021

Public Version Number

1

DI Record Publish Date

April 14, 2021

Package DI Number

16930518032167

Quantity per Package

50

Contains DI Package

06930518032160

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box