Busse Hospital Disposables - Sterile Dressing Change Tray - ROBERT BUSSE & CO., INC.

Duns Number:002418234

Device Description: Sterile Dressing Change Tray

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More Product Details

Catalog Number

4479

Brand Name

Busse Hospital Disposables

Version/Model Number

4479

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

MCY

Product Code Name

Wound Dressing Kit

Device Record Status

Public Device Record Key

2aa3e9f4-a6e1-46a7-a1ff-c431ffd87da6

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

10849233006208

Quantity per Package

20

Contains DI Package

00849233006201

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"ROBERT BUSSE & CO., INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 31
2 A medical device with a moderate to high risk that requires special controls. 298