Catalog Number

584

Brand Name

Busse Hospital Disposables

Version/Model Number

584

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

K131006,K131006,K131006

Product Code

BSP

Product Code Name

Needle, Conduction, Anesthetic (W/Wo Introducer)

Public Device Record Key

deefe556-80dd-400f-ae04-603b95d5cca5

Public Version Date

October 07, 2021

Public Version Number

1

DI Record Publish Date

September 29, 2021

Package DI Number

10849233005836

Quantity per Package

25

Contains DI Package

00849233005839

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-