Catalog Number

-

Brand Name

Cypress

Version/Model Number

27-26

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"

-

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

K071119,K071119,K071119

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

d1388733-cee3-4c99-a4ea-e218eb03f89f

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

May 20, 2020

Package DI Number

20815555020779

Quantity per Package

10

Contains DI Package

10815555020772

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case