Duns Number:440211428
Device Description: Bone marrow biopsy needle 8G x 150 mm
Catalog Number
-
Brand Name
MEDBONE
Version/Model Number
MB08150-10
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
K172344,K172344
Product Code
KNW
Product Code Name
Instrument, Biopsy
Public Device Record Key
5475c3c7-a9f8-4176-ae86-42f0bbe819b3
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
April 10, 2018
Package DI Number
18056772675846
Quantity per Package
10
Contains DI Package
08056772675849
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 | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 436 |