Catalog Number

599

Brand Name

Busse Hospital Disposables

Version/Model Number

599

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

K052843,K052843

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

2a4d20f7-aefe-41b4-bf0f-8a564d88c894

Public Version Date

February 21, 2019

Public Version Number

4

DI Record Publish Date

September 16, 2016

Package DI Number

10849233011769

Quantity per Package

1000

Contains DI Package

00849233011762

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-