Glatopaject®

Basic Information

• Brand Name: Glatopaject®
• Primary DI: 57613421039603
• Version / Model: 49036228
• Catalog Number: 49020084
• Company Name: Sandoz GmbH
• Labeler DUNS: 300220969
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-21
• Public Version: 4
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: dfa2b457-fdb9-48a1-8d9e-9dea8610a363

Device Description

The Glatopaject® is a reusable injection device for the subcutaneous injection of Glatopa®. The Glatopaject® is intended for use with Glatopa® (Glatiramer Acetate Injection) Pre-Filled Syringe.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KZH	Introducer, Syringe Needle	General Hospital	880.6920	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62117	Syringe-loaded medication/vaccine injector, manual, home-use	A hand-held, manually-powered, mechanical device intended to be used in conjunction with an appropriate plunger syringe and needle for the self-administration of a medication or vaccine to a patient intramuscularly (IM) and/or subcutaneously; it is not intended for intradermal injection. It is typically a spring-loaded mechanical assembly intended to accept a prefilled syringe and needle; the syringe, needle and pharmaceutical are not included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	57613421039603	GS1
Direct Marking	47612799221545	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]