Catalog Number

-

Brand Name

N/A

Version/Model Number

MR190000

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KGO

Product Code Name

Surgeon'S Gloves

Public Device Record Key

df4376f5-f2c4-4f90-9dac-8270f92ec1d8

Public Version Date

September 23, 2019

Public Version Number

2

DI Record Publish Date

July 09, 2019

Package DI Number

50884908033538

Quantity per Package

5

Contains DI Package

00884908033533

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX