Catalog Number

5192

Brand Name

Busse Hospital Disposables

Version/Model Number

5192

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LRO

Product Code Name

General Surgery Tray

Public Device Record Key

ee462018-2310-44cf-bdd8-0d821838cf81

Public Version Date

June 17, 2022

Public Version Number

4

DI Record Publish Date

September 22, 2016

Package DI Number

10849233006604

Quantity per Package

3

Contains DI Package

00849233006607

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-