Extavia® Auto-Injector II

GUDID 47612799202391

Reusable auto-injector for the subcutaneous injection of Extavia® for the treatment of Multiple Sclerosis.

NOVARTIS PHARMACEUTICALS CORPORATION

General-purpose syringe, single-use General-purpose syringe, single-use

• Primary Device ID: 47612799202391
• NIH Device Record Key: c021ecac-a600-4232-9aa3-f8c871d40ee8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Extavia® Auto-Injector II
• Version Model Number: 920239
• Company DUNS: 002147023
• Company Name: NOVARTIS PHARMACEUTICALS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-669-6682
• Email: Novartis.email@novartis.com
• Phone: 888-669-6682
• Email: Novartis.email@novartis.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	47612799202391 [Direct Marking]
GS1	57612799202398 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993385

FDA Product Code

• KZH: Introducer, Syringe Needle

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-25
• Device Publish Date: 2018-09-24