Duns Number:276816717
Device Description: NUCLISENS EASYMAG DISPOSABLE are intended to be used with NucliSENS easyMAG.
Catalog Number
-
Brand Name
NUCLISENS® easyMAG® Disposables
Version/Model Number
NUCLISENS® easyMAG® Disposables
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
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
JJH
Product Code Name
CLINICAL SAMPLE CONCENTRATOR
Public Device Record Key
4f976ffe-79a6-4601-8708-7713937426bc
Public Version Date
September 26, 2022
Public Version Number
3
DI Record Publish Date
April 06, 2020
Package DI Number
03573026139360
Quantity per Package
48
Contains DI Package
03573026616618
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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 156 |
| 3 | A medical device with high risk that requires premarket approval | 3 |