Glatopaject® 49020084

GUDID 57613421039603

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.

Sandoz GmbH

Syringe-loaded injector, manual, home-use

• Primary Device ID: 57613421039603
• NIH Device Record Key: dfa2b457-fdb9-48a1-8d9e-9dea8610a363
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Glatopaject®
• Version Model Number: 49036228
• Catalog Number: 49020084
• Company DUNS: 300220969
• Company Name: Sandoz GmbH
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-525-8747
• Email: qa.druginfo@sandoz.com
• Phone: 1-800-525-8747
• Email: qa.druginfo@sandoz.com
• Phone: 1-800-525-8747
• Email: qa.druginfo@sandoz.com
• Phone: 1-800-525-8747
• Email: qa.druginfo@sandoz.com
• Phone: 1-800-525-8747
• Email: qa.druginfo@sandoz.com
• Phone: 1-800-525-8747
• Email: qa.druginfo@sandoz.com
• Phone: 1-800-525-8747
• Email: qa.druginfo@sandoz.com
• Phone: 1-800-525-8747
• Email: qa.druginfo@sandoz.com
• Phone: 1-800-525-8747
• Email: qa.druginfo@sandoz.com
• Phone: 1-800-525-8747
• Email: qa.druginfo@sandoz.com
• Phone: 1-800-525-8747
• Email: qa.druginfo@sandoz.com
• Phone: 1-800-525-8747
• Email: qa.druginfo@sandoz.com
• Phone: 1-800-525-8747
• Email: qa.druginfo@sandoz.com
• Phone: 1-800-525-8747
• Email: qa.druginfo@sandoz.com
• Phone: 1-800-525-8747
• Email: qa.druginfo@sandoz.com
• Phone: 1-800-525-8747
• Email: qa.druginfo@sandoz.com
• Phone: 1-800-525-8747
• Email: qa.druginfo@sandoz.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	47612799221545 [Direct Marking]
GS1	57613421039603 [Primary]

FDA Product Code

• KZH: Introducer, Syringe Needle

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-10-27
• Device Publish Date: 2016-11-21

On-Brand Devices [Glatopaject®]

• 59002269209466: The Glatopaject® is a reusable injection device for the subcutaneous injection of Glatopa®. Th
• 57613421039603: The Glatopaject® is a reusable injection device for the subcutaneous injection of Glatopa®. Th