Duns Number:832696038
Device Description: Safe-T PLUS Jamshidi Evolve Bone Marrow Biopsy Tray - 11G x 4" EJ Biopsy/Aspiration Needle Safe-T PLUS Jamshidi Evolve Bone Marrow Biopsy Tray - 11G x 4" EJ Biopsy/Aspiration Needle with Marrow Acquisition Cradle
Catalog Number
BEJS3411SP
Brand Name
Safe-T
Version/Model Number
BEJS3411SP
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
-
Product Code
KNW
Product Code Name
INSTRUMENT, BIOPSY
Public Device Record Key
8db83a98-4ea1-4fa7-95b6-5de9142b854b
Public Version Date
July 06, 2018
Public Version Number
1
DI Record Publish Date
June 05, 2018
Package DI Number
50885403471573
Quantity per Package
10
Contains DI Package
10885403471575
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 | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |