FDA.reportPublic FDA data

Cartridge-accepting autoinjector, 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 to subcutaneously inject a dose of the pharmaceutical agent via a replaceable needle. The cartridge is inserted into the device and typically a dial on the device is operated for dosing (e.g., via a spring-loaded mechanism); the cartridge is replaced once the pharmaceutical is exhausted. This is a reusable device.
GUDID devices
27
Last updated
2024-01-09 08:12:29

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
60840164519442FOLLISTIM PEN STARTER KITOrganon LLC10449422024-01-01
60840164519459FOLLISTIM PEN STARTER KIT SAMOrganon LLC10449432024-01-01
47612799222856Omnitrope Pen 10Sandoz GmbH490414592023-02-07
47612799222849Omnitrope Pen 5Sandoz GmbH490414802023-02-07
49002269218553Omnitrope Pen 10Sandoz GmbH490414592023-02-07
00763000645281inpen™COMPANION MEDICAL, INC.MMT-105EVNNWW2022-08-08
00763000645298inpen™COMPANION MEDICAL, INC.MMT-105EVELWW2022-08-08
10358406480016AutoTouch Connect reusable autoinjectorAMGEN INC.90069402021-11-08
62088-0000-31InPen Smart Insulin Delivery SystemCOMPANION MEDICAL, INC.Lilly - Blue2017-05-01
62088-0000-32InPen Smart Insulin Delivery SystemCOMPANION MEDICAL, INC.Lilly - Grey2017-05-01
62088-0000-33InPen Smart Insulin Delivery SystemCOMPANION MEDICAL, INC.Lilly - Pink2017-05-01
62088-0000-34InPen Smart Insulin Delivery SystemCOMPANION MEDICAL, INC.Novo - Blue2017-05-01
62088-0000-35InPen Smart Insulin SystemCOMPANION MEDICAL, INC.Novo - Grey2017-05-01
62088-0000-36InPen Smart Insulin Delivery SystemCOMPANION MEDICAL, INC.Novo - Pink2017-05-01
60300520311535FOLLISTIM PEN STARTER KIT SAM USAMERCK SHARP & DOHME CORP.17468112019-10-28
10358406470017AutoTouch reusable autoinjectorAMGEN INC.90036002019-09-24
00300029560012HumatroPen® 6 mgELI LILLY AND COMPANYMS95602019-09-16
30300029561010HumatroPen® 12 mg ELI LILLY AND COMPANYMS95612019-09-16
30300029562017HumatroPen® 24 mg ELI LILLY AND COMPANYMS95622019-09-16
10300132647034Genotropin Pen® 12PHARMACIA & UPJOHN COMPANY LLCF0000991112019-09-05
10300134761929Genotropin Pen® 5PHARMACIA & UPJOHN COMPANY LLCF0001161532019-09-05
04054839025792one.clickEMD Serono, Inc.U12224022019-04-11
00300029673019HumaPen® Luxura™ HD ELI LILLY AND COMPANYMS96732016-09-21
30300029675014HumaPen® Luxura™ HD - SAMPLEELI LILLY AND COMPANYMS96752017-05-25
30301691854592NovoPen Echo®NOVO NORDISK INC.1854592016-11-23
00384703800014Autopen OWEN MUMFORD LIMITEDAN38002016-09-19
00384703810013Autopen OWEN MUMFORD LIMITEDAN38102016-09-19