Catalog Number

-

Brand Name

Cypress

Version/Model Number

27-32

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 04, 2022

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"

-

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

922697a4-185f-46c1-8823-6befd20ebd2b

Public Version Date

February 07, 2022

Public Version Number

3

DI Record Publish Date

May 22, 2020

Package DI Number

00815555024193

Quantity per Package

10

Contains DI Package

00815555024186

Package Discontinue Date

February 04, 2022

Package Status

Not in Commercial Distribution

Package Type

Case