Catalog Number

835

Brand Name

Busse Hospital Disposables

Version/Model Number

835

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

MCY

Product Code Name

Wound Dressing Kit

Public Device Record Key

612d19d0-f698-42cc-8c17-dea91f541023

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Package DI Number

10849233010625

Quantity per Package

30

Contains DI Package

00849233010628

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-