Duns Number:440211428
Device Description: Bone Marrow Biopsy and Aspiration System 8G x 10 cm
Catalog Number
-
Brand Name
MED-J
Version/Model Number
XJ08100-00
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
eb7af2d1-4560-4535-9d63-716e8b747ba6
Public Version Date
July 15, 2020
Public Version Number
1
DI Record Publish Date
July 07, 2020
Package DI Number
18054301668666
Quantity per Package
10
Contains DI Package
08054301668669
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 |