Identity
- Trade Name
- Extavia® Auto-Injector II FDA UDI
- Generic Name
- General-purpose syringe, single-use FDA UDI
- Device Name
- Reusable auto-injector for the subcutaneous injection of Extavia® for the treatment of Multiple Sclerosis. FDA UDI
- Model / Reference
- 920239 FDA UDI
- Description
- Reusable auto-injector for the subcutaneous injection of Extavia® for the treatment of Multiple Sclerosis. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 57612799202398 FDA UDI
- 510(k) Number
- K993385 FDA UDI
- FDA Product Code
- KZH FDA UDI
- GMDN Term
- General-purpose syringe, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6920 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose syringe, single-use
Extavia® Auto-Injector II by Novartis Pharmaceuticals Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General-purpose syringe, single-use.
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Cleared under the same submission
K993385 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Novartis Pharmaceuticals Corporation
Sources (1)
- FDA UDI c021ecac-a600-4232-9aa3-f8c871d40ee8 35 fields · synced May 30, 2026