Catalog Number

-

Brand Name

Beesure

Version/Model Number

BE2620

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

01f774cc-36b6-4cd1-a37f-5d4000aee97c

Public Version Date

June 16, 2022

Public Version Number

1

DI Record Publish Date

June 08, 2022

Package DI Number

20817508023424

Quantity per Package

8

Contains DI Package

10817508023427

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case