Catalog Number

-

Brand Name

Bessure

Version/Model Number

BE2410

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

LYU

Product Code Name

Accessory, Surgical Apparel

Public Device Record Key

a2880e02-47e5-43cd-b53c-9d8e563af0e7

Public Version Date

June 22, 2022

Public Version Number

3

DI Record Publish Date

December 07, 2021

Package DI Number

20817508020737

Quantity per Package

8

Contains DI Package

10817508020730

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case