Catalog Number

2815

Brand Name

Busse Hospital Disposables

Version/Model Number

2815

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

6d93c4d9-ad4d-42db-bd31-dc8db3444567

Public Version Date

April 16, 2020

Public Version Number

1

DI Record Publish Date

April 08, 2020

Package DI Number

10849233001265

Quantity per Package

20

Contains DI Package

00849233001268

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-