Catalog Number

-

Brand Name

MocareHealth

Version/Model Number

1610/7

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K063757,K063757

Product Code

KGO

Product Code Name

Surgeon'S Gloves

Public Device Record Key

15a00842-e95e-4593-8cb5-caa5c7d40cc9

Public Version Date

September 03, 2021

Public Version Number

1

DI Record Publish Date

August 26, 2021

Package DI Number

36971384150887

Quantity per Package

6

Contains DI Package

26971384150880

Package Discontinue Date

August 26, 2026

Package Status

In Commercial Distribution

Package Type

CASE