Duns Number:809012870
Catalog Number
RO-300
Brand Name
Magellan® Complete Disposable kit
Version/Model Number
RO-300
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 04, 2019
Issuing Agency
In HIBCC
MRI safety Status
MR Safe
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
-
Product Code
-
Product Code Name
-
Public Device Record Key
b80dc664-e770-4fac-842c-d1fd388b2730
Public Version Date
July 23, 2020
Public Version Number
5
DI Record Publish Date
November 06, 2017
Package DI Number
M896RO3001
Quantity per Package
5
Contains DI Package
M896RO3000
Package Discontinue Date
November 04, 2019
Package Status
Not 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 | 6 |
2 | A medical device with a moderate to high risk that requires special controls. | 16 |