Catalog Number

987

Brand Name

Busse Hospital Disposables

Version/Model Number

987

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 15, 2022

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

PRV

Product Code Name

Gastro-Urology Biopsy Kit

Public Device Record Key

4d2cc541-7f11-44d4-9eb8-abd87e4ecf99

Public Version Date

July 18, 2022

Public Version Number

2

DI Record Publish Date

November 23, 2020

Package DI Number

10849233013824

Quantity per Package

10

Contains DI Package

00849233013827

Package Discontinue Date

July 15, 2022

Package Status

Not in Commercial Distribution

Package Type

-