FDA.reportPublic FDA data

Empty self-injector, mechanical

Definition
A portable, hand-held, mechanical device, typically in the form of a large pen, designed to accept a pharmaceutical-containing cartridge (not included) and intended to be used by a patient or carer for subcutaneous or intramuscular injection of a dose of the pharmaceutical agent via a replaceable needle. A dial on the injector is operated for dosing (e.g., via a spring-loaded mechanism). This is a reusable device.
GUDID devices
29
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00300029561019HumatroPen® 12 mg ELI LILLY AND COMPANYMS95612019-09-16
00300029562016HumatroPen® 24 mg ELI LILLY AND COMPANYMS95622019-09-16
00300029675013HumaPen® Luxura™ HD - SAMPLEELI LILLY AND COMPANYMS96752017-05-25
00300520311533FOLLISTIM PEN STARTER KIT SAM USAMerck Sharp & Dohme LLC17468112019-10-28
00301691854591NovoPen Echo®NOVO NORDISK INC.1854592016-11-23
00358406470010AutoTouch reusable autoinjectorAMGEN INC.90036002019-09-24
00358406480019AutoTouch Connect reusable autoinjectorAMGEN INC.90069402021-11-08
00840164519440FOLLISTIM PEN STARTER KITOrganon LLC10449422024-01-01
00840164519457FOLLISTIM PEN STARTER KIT SAMOrganon LLC10449432024-01-01
10862088000313InPen Smart Insulin Delivery SystemCOMPANION MEDICAL, INC.Lilly - Blue2017-05-01
10862088000320InPen Smart Insulin Delivery SystemCOMPANION MEDICAL, INC.Lilly - Grey2017-05-01
10862088000337InPen Smart Insulin Delivery SystemCOMPANION MEDICAL, INC.Lilly - Pink2017-05-01
10862088000344InPen Smart Insulin Delivery SystemCOMPANION MEDICAL, INC.Novo - Blue2017-05-01
10862088000351InPen Smart Insulin SystemCOMPANION MEDICAL, INC.Novo - Grey2017-05-01
10862088000368InPen Smart Insulin Delivery SystemCOMPANION MEDICAL, INC.Novo - Pink2017-05-01
57612799210546Omnitrope Pen 10Sandoz GmbH490414592023-02-07
57622436000010Omnitrope® Pen 10Sandoz Inc.490414592023-10-05
57622436000027Omnitrope® Pen 5Sandoz Inc.490414802023-10-05
59002269207349Omnitrope Pen 5Sandoz GmbH490362292023-02-07
00763000974589InPenMEDTRONIC MINIMED, INC.MMT-80602025-04-29
00763000974596InPenMEDTRONIC MINIMED, INC.MMT-80612025-04-29
00763000489953InPen Smart Insulin Delivery SystemMEDTRONIC MINIMED, INC.MMT-80602025-03-08
00763000489960InPen Smart Insulin Delivery SystemMEDTRONIC MINIMED, INC.MMT-80612025-03-08
00763000827182inpen™MEDTRONIC MINIMED, INC.MMT-105NNBLNA2024-06-03
00763000827199inpen™MEDTRONIC MINIMED, INC.MMT-105NNGYNA2024-06-03
00763000827205inpen™MEDTRONIC MINIMED, INC.MMT-105NNPKNA2024-06-03
00763000827151inpen™MEDTRONIC MINIMED, INC.MMT-105ELBLNA2024-05-31
00763000827168inpen™MEDTRONIC MINIMED, INC.MMT-105ELGYNA2024-05-31
00763000827175inpen™MEDTRONIC MINIMED, INC.MMT-105ELPKNA2024-06-02