Duns Number:301237509
Device Description: This media contains V 7.3 of the following registered Medical Devices:(DI)09120052070880 ( This media contains V 7.3 of the following registered Medical Devices:(DI)09120052070880 (SOFTWARE MAGELLAN PRO V 7.X),(DI)09120052070910 (SOFTWARE MAGELLAN PRO TRACKER V 7.X)
Catalog Number
30204301
Brand Name
USB-STICK MAGELLAN PRO V 7.5
Version/Model Number
30204301 00
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JQP
Product Code Name
Calculator/Data Processing Module, For Clinical Use
Public Device Record Key
5b36f42f-c2a2-4ce4-9806-0e809ddb9479
Public Version Date
June 03, 2022
Public Version Number
1
DI Record Publish Date
May 26, 2022
Package DI Number
09120052071269
Quantity per Package
2
Contains DI Package
09120052071238
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton Box.
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |