Catalog Number

386

Brand Name

Busse Hospital Disposables

Version/Model Number

386

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

OHG

Product Code Name

Circumcision Tray

Public Device Record Key

5ae88697-ffad-4140-88dc-fa751baaa6d8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 01, 2016

Package DI Number

10849233013046

Quantity per Package

10

Contains DI Package

00849233013049

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-