Duns Number:002418234
Device Description: Safety Deluxe bone Marrow Biopsy/Aspiration Tray with Snare-it marrow acquisition & Aspira Safety Deluxe bone Marrow Biopsy/Aspiration Tray with Snare-it marrow acquisition & Aspiration needle
Catalog Number
988
Brand Name
Busse Hospital Disposables
Version/Model Number
988
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 15, 2022
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
PRV
Product Code Name
Gastro-Urology Biopsy Kit
Public Device Record Key
1ff9e2d5-7250-4ab7-ab40-9ccba1675687
Public Version Date
July 18, 2022
Public Version Number
5
DI Record Publish Date
September 02, 2016
Package DI Number
10849233013831
Quantity per Package
10
Contains DI Package
00849233013834
Package Discontinue Date
July 15, 2022
Package Status
Not in Commercial Distribution
Package Type
-
| 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 |