FDA.reportPublic FDA data

Glatopaject ®

Primary DI
47622436104100
Brand
Glatopaject ®
Company
AEROPHARM GmbH
Model
49047024
Catalog number
49048215
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.
Published
2025-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KZHIntroducer, Syringe Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZHIntroducer, Syringe NeedleGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
47622436104100Direct MarkingGS10
57613421039603PreviousGS10
57622436104114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4762243610410047622436104100
5761342103960357613421039603
5762243610411457622436104114

GMDN Terms#

Term, Definition table
TermDefinition
Syringe-loaded medication/vaccine injector, manual, home-useA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-525-8747qa.druginfo@sandoz.com

Regulatory Flags#

DUNS number
499181139
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
57622436104114Glatopaject ®49047024490482152025-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B33919800010V-CathNeo Medical Inc.KZH2026-03-27
05713495000121SKYTROFA Auto-InjectorPhillips-Medisize A/SKZH2025-08-20
05713495000138SKYTROFA Auto-InjectorPhillips-Medisize A/SKZH2025-08-20
57622436104114Glatopaject ®AEROPHARM GmbHKZH2025-08-19
00860010587317CoolJect Targeted-Mist 1-3cc Nook Syringe Holder AccessoryVapocoolshot, IncKZH2025-08-01
00850037806058Orbit InserterModular Medical, Inc.KZH2025-07-11
00850037806119MODD1 Starter KitModular Medical, Inc.KZH2025-07-11
00850037806126MODD1 Patient Welcome KitModular Medical, Inc.KZH2025-07-11
00370095000002GripMate™SUN PHARMACEUTICAL INDUSTRIES, INC.KZH2025-05-12
05714472000004Needle Guide AssistantUnion Medico ApSKZH2025-05-05
B33935290030NeoMagicNeo Medical Inc.KZH2025-01-22
B33935290035NeoMagicNEO MEDICAL INC.KZH2025-01-22
00860006961510Coolject 1-3cc Syringe Holder Nozzle AccessoryVapocoolshot, IncKZH2023-01-27
00860006961534Coolject 1-3cc Syringe Holder Nozzle AccessoryVapocoolshot, IncKZH2023-01-27
00817708022964AccuSertEMED TECHNOLOGIES CORPORATIONKZH2022-10-24
00817708022988AccuSertEMED TECHNOLOGIES CORPORATIONKZH2022-10-24
00643169705920Sil-serter™MEDTRONIC MINIMED, INC.KZH2022-09-17
00643169768086Minimed™ Quick-serter™MEDTRONIC MINIMED, INC.KZH2022-07-07
00763000573690MiniMed™ Quick-serter™MEDTRONIC MINIMED, INC.KZH2022-07-07
05713495000077Skytrofa Auto-InjectorPhillips-Medisize A/SKZH2021-10-22
05713495000084Skytrofa Auto-InjectorPhillips-Medisize A/SKZH2021-10-22
00763000381080Sil-serter™MEDTRONIC MINIMED, INC.KZH2021-04-22
00763000354817MiniMed™ Quick-serter™MEDTRONIC MINIMED, INC.KZH2020-06-14
05713495000015BETACONNECTPhillips-Medisize A/SKZH2019-10-07
00355513192019Onpro kitAMGEN INC.KZH2019-09-24
10355513192016Onpro kitAMGEN INC.KZH2019-09-24
00301697712901FlexPro® PenMate®NOVO NORDISK INC.KZH2019-08-08
00025294874007Inject-EaseAMBI, INC.KZH2018-12-17
57612799202398Extavia® Auto-Injector IINOVARTIS PHARMACEUTICALS CORPORATIONKZH2018-09-24
47612799202391Extavia® Auto-Injector IINOVARTIS PHARMACEUTICALS CORPORATIONKZH2018-09-24