Catalog Number

-

Brand Name

Busse Hospital Disposables

Version/Model Number

148

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

KYZ

Product Code Name

Syringe, Irrigating (Non Dental)

Public Device Record Key

65caa066-f47b-4724-88c3-353cc50e4717

Public Version Date

April 08, 2022

Public Version Number

1

DI Record Publish Date

March 31, 2022

Package DI Number

10849233012872

Quantity per Package

24

Contains DI Package

00849233012875

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-