Catalog Number

-

Brand Name

MediChoice

Version/Model Number

GLV2703

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

545386d7-f694-4fa5-b34c-5d250086518f

Public Version Date

October 21, 2020

Public Version Number

1

DI Record Publish Date

October 13, 2020

Package DI Number

30885632291641

Quantity per Package

10

Contains DI Package

20885632291644

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-