Catalog Number

8117

Brand Name

Busse Hospital Disposables

Version/Model Number

8117

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

8687a3e8-027c-4f01-b955-f635e6240a59

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

September 22, 2016

Package DI Number

10849233015774

Quantity per Package

10

Contains DI Package

00849233015777

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-