Duns Number:135057938
Device Description: JAMSHIDI EVOLVE BONE MARROW BIOPSY/ASPIRATION NEEDLE 11GX8 CRADLE
Catalog Number
EJM8011
Brand Name
Jamshidi
Version/Model Number
EJM8011
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"
-
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
KNW
Product Code Name
INSTRUMENT, BIOPSY
Public Device Record Key
9ccb514d-c4fc-4c24-b2ea-ca761100e13f
Public Version Date
November 20, 2020
Public Version Number
3
DI Record Publish Date
October 02, 2017
Package DI Number
50885403464193
Quantity per Package
10
Contains DI Package
10885403464195
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 | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2835 |
| 3 | A medical device with high risk that requires premarket approval | 190 |