Duns Number:002147023
Device Description: Reusable auto-injector for the subcutaneous injection of Extavia® for the treatment of Mul Reusable auto-injector for the subcutaneous injection of Extavia® for the treatment of Multiple Sclerosis.
Catalog Number
-
Brand Name
Extavia® Auto-Injector II
Version/Model Number
920239
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K993385,K993385
Product Code
KZH
Product Code Name
Introducer, Syringe Needle
Public Device Record Key
c021ecac-a600-4232-9aa3-f8c871d40ee8
Public Version Date
October 25, 2018
Public Version Number
1
DI Record Publish Date
September 24, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |