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
30141795
Brand Name
USB-STICK MAGELLAN PRO V 7.3
Version/Model Number
30141795 00
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 30, 2021
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
6e88f1cb-7029-48c8-a3b5-f335be654315
Public Version Date
March 22, 2022
Public Version Number
5
DI Record Publish Date
January 07, 2020
Package DI Number
09120052070934
Quantity per Package
1
Contains DI Package
09120052070941
Package Discontinue Date
June 30, 2021
Package Status
Not 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 |