Catalog Number

88ES

Brand Name

ESTEEM

Version/Model Number

88ES

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)

Yes

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

8efd5b76-f453-4e84-93cd-5b872fd68a76

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

November 07, 2019

Package DI Number

50885380166196

Quantity per Package

100

Contains DI Package

20885380166195

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE