Catalog Number

142

Brand Name

Busse Hospital Disposables

Version/Model Number

142

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

cca20fbc-ede4-4651-97ba-683a8ecbda5d

Public Version Date

June 11, 2021

Public Version Number

1

DI Record Publish Date

June 03, 2021

Package DI Number

10849233012629

Quantity per Package

50

Contains DI Package

00849233012622

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-