Catalog Number

653

Brand Name

Busse Hospital Disposables

Version/Model Number

653

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

PRV

Product Code Name

Gastro-Urology Biopsy Kit

Public Device Record Key

2a536246-7e17-4f88-87ca-bfecc7a8e49c

Public Version Date

November 24, 2020

Public Version Number

4

DI Record Publish Date

September 02, 2016

Package DI Number

10849233013268

Quantity per Package

10

Contains DI Package

00849233013261

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-