Duns Number:301237509
Device Description: This media contains V 7.4 of the following registered Medical Devices:(DI)09120052070880 ( This media contains V 7.4 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
30185384
Brand Name
USB-STICK MAGELLAN PRO V7.4
Version/Model Number
30185384 00
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 17, 2022
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
-
Product Code
JQP
Product Code Name
Calculator/Data Processing Module, For Clinical Use
Public Device Record Key
39f5077b-9b8f-42ea-855e-c056c924f98e
Public Version Date
August 18, 2022
Public Version Number
3
DI Record Publish Date
January 07, 2021
Package DI Number
09120052071108
Quantity per Package
1
Contains DI Package
09120052071092
Package Discontinue Date
August 17, 2022
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 |