Duns Number:315654579
Device Description: For use with Bone Marrow Collection Kit
Catalog Number
X6R2105
Brand Name
Bone Marrow Collection Stand
Version/Model Number
X6R2105
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
-
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
a5f562ba-8024-4223-a2e9-500e46dd3456
Public Version Date
August 25, 2022
Public Version Number
1
DI Record Publish Date
August 17, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 87 |
| U | Unclassified | 2 |