Catalog Number

-

Brand Name

MediChoice

Version/Model Number

Testing321

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LZA

Product Code Name

Polymer patient examination glove

Public Device Record Key

77272191-634b-4550-b309-a551e8a5df0c

Public Version Date

June 28, 2021

Public Version Number

1

DI Record Publish Date

June 18, 2021

Package DI Number

20885632353120

Quantity per Package

50

Contains DI Package

10885632353123

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-