Duns Number:440211428
Device Description: Bone Marrow Biopsy and Aspiration System 11G x 15 cm
Catalog Number
-
Brand Name
MED-J
Version/Model Number
XJ11150-00
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K192099,K192099
Product Code
KNW
Product Code Name
Instrument, Biopsy
Public Device Record Key
5ee16524-beff-4c26-945b-42fd7b54ca63
Public Version Date
July 15, 2020
Public Version Number
1
DI Record Publish Date
July 07, 2020
Package DI Number
18054301668680
Quantity per Package
10
Contains DI Package
08054301668683
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 436 |