Duns Number:002418234
Device Description: J-Style Bone Marrow Biopsy / Aspiration Needle, 11 G x 4"
Catalog Number
630
Brand Name
Busse Hospital Disposables
Version/Model Number
630
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
K092338,K092338
Product Code
KNW
Product Code Name
Instrument, Biopsy
Public Device Record Key
41cc0172-6fed-44ce-af3e-2b86c2ddcd9e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
10849233001593
Quantity per Package
10
Contains DI Package
00849233001596
Package Discontinue Date
-
Package Status
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 |