Duns Number:002348191
Device Description: ARROW(R) OnControl(R) Bone Marrow Biopsy System Kit
Catalog Number
ASK-09458-AH
Brand Name
ARROW
Version/Model Number
IPN922906
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K142377,K142377
Product Code
KNW
Product Code Name
INSTRUMENT, BIOPSY
Public Device Record Key
03ef3d6c-a186-4d83-9fb2-483153830ed5
Public Version Date
June 21, 2022
Public Version Number
2
DI Record Publish Date
April 08, 2022
Package DI Number
20801902203179
Quantity per Package
5
Contains DI Package
10801902203172
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |