Duns Number:832696038
Device Description: Bone Marrow Biopsy Drug Free Tray Without Needle
Catalog Number
BK1000DF
Brand Name
N/A
Version/Model Number
BK1000DF
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
LWE
Product Code Name
Bone marrow collection/transfusion kit
Public Device Record Key
53b13e58-bbf2-4ed5-979a-139e6c53b03b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 21, 2017
Package DI Number
50885403231801
Quantity per Package
10
Contains DI Package
10885403231803
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 |