Catalog Number

-

Brand Name

Beesure

Version/Model Number

BE1118

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

6a08b03b-3942-4a4d-94b8-203cdb8b1030

Public Version Date

June 21, 2022

Public Version Number

5

DI Record Publish Date

July 05, 2019

Package DI Number

20817508020102

Quantity per Package

10

Contains DI Package

10817508020105

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case