Busse Hospital Disposables - 9mm Curved Vacuum Curette - ROBERT BUSSE & CO., INC.

Duns Number:002418234

Device Description: 9mm Curved Vacuum Curette

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More Product Details

Catalog Number

281

Brand Name

Busse Hospital Disposables

Version/Model Number

281

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

HCY

Product Code Name

Curette, Uterine

Device Record Status

Public Device Record Key

e369f547-371b-4b9c-bf79-f133d8af961d

Public Version Date

May 18, 2020

Public Version Number

1

DI Record Publish Date

May 08, 2020

Additional Identifiers

Package DI Number

10849233009797

Quantity per Package

25

Contains DI Package

00849233009790

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