Duns Number:121622872
Device Description: MAXX-CELL Bone Marrow Aspirate Kit w/ Biopsy Needle11GA X 11CM MAX-CELL Needle8GA X 10CM R MAXX-CELL Bone Marrow Aspirate Kit w/ Biopsy Needle11GA X 11CM MAX-CELL Needle8GA X 10CM RJN-810PN 74340-03M
Catalog Number
BM-MXC-3
Brand Name
MAXX-CELL
Version/Model Number
11GA X 11CM
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
K150563,K150563,K150563
Product Code
KNW
Product Code Name
Instrument, Biopsy
Public Device Record Key
8cc56f13-ccf1-4f62-9b01-d4d5405d1a63
Public Version Date
September 02, 2019
Public Version Number
1
DI Record Publish Date
August 23, 2019
Package DI Number
10857878007825
Quantity per Package
1
Contains DI Package
00857878007828
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner
| 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. | 93 |