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 ID57613421039603
NIH Device Record Keydfa2b457-fdb9-48a1-8d9e-9dea8610a363
Commercial Distribution StatusIn Commercial Distribution
Brand NameGlatopaject®
Version Model Number49036228
Catalog Number49020084
Company DUNS300220969
Company NameSandoz GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-525-8747
Emailqa.druginfo@sandoz.com
Phone1-800-525-8747
Emailqa.druginfo@sandoz.com
Phone1-800-525-8747
Emailqa.druginfo@sandoz.com
Phone1-800-525-8747
Emailqa.druginfo@sandoz.com
Phone1-800-525-8747
Emailqa.druginfo@sandoz.com
Phone1-800-525-8747
Emailqa.druginfo@sandoz.com
Phone1-800-525-8747
Emailqa.druginfo@sandoz.com
Phone1-800-525-8747
Emailqa.druginfo@sandoz.com
Phone1-800-525-8747
Emailqa.druginfo@sandoz.com
Phone1-800-525-8747
Emailqa.druginfo@sandoz.com
Phone1-800-525-8747
Emailqa.druginfo@sandoz.com
Phone1-800-525-8747
Emailqa.druginfo@sandoz.com
Phone1-800-525-8747
Emailqa.druginfo@sandoz.com
Phone1-800-525-8747
Emailqa.druginfo@sandoz.com
Phone1-800-525-8747
Emailqa.druginfo@sandoz.com
Phone1-800-525-8747
Emailqa.druginfo@sandoz.com
Phone1-800-525-8747
Emailqa.druginfo@sandoz.com

Device Identifiers

Device Issuing AgencyDevice ID
GS147612799221545 [Direct Marking]
GS157613421039603 [Primary]

FDA Product Code

KZHIntroducer, Syringe Needle

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-10-27
Device Publish Date2016-11-21

On-Brand Devices [Glatopaject®]

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

Trademark Results [Glatopaject]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GLATOPAJECT
GLATOPAJECT
85575333 4804363 Live/Registered
Novartis AG
2012-03-21

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