FDA.reportPublic FDA data

SKYTROFA Auto-Injector

Primary DI
05713495000138
Brand
SKYTROFA Auto-Injector
Company
Phillips-Medisize A/S
Model
02
Device description
The SKYTROFA Auto-Injector is intended to automate the reconstitution (mixing) and subcutaneous (under the skin) injection of lonapegsomatropin in patients prescribed once weekly growth hormone therapy.
Published
2025-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
05713495000114Direct MarkingGS10
05713495000138PackageGS110In Commercial Distribution
05713495000121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713495000114057134950001145713495000114
05713495000138057134950001385713495000138
05713495000121057134950001215713495000121

GMDN Terms#

Term, Definition table
TermDefinition
Empty self-injector, electronicA portable, hand-held, battery-powered device, commonly referred to as an electronic autoinjector, 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. The device includes an electronic display and may be capable of a variety of dose-recording functions. The needle is replaced for each administration. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth1.06Inch
Length7.09Inch
Weight150Gram
Width1.46Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit
Storage Environment Temperature14 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-844-442-7236JDW@AscendisPharma.com

Regulatory Flags#

DUNS number
306047440
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
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
05713495001128VYAFUSER™VYAFUSER PUMP KIT US (R)20898704102025-09-03
05713495000121SKYTROFA Auto-Injector022025-08-20
05713495000077Skytrofa Auto-Injector10022472021-10-22
05713495000152VYAFUSER™VYAFUSER PUMP KIT US/PR A20898704102024-11-13
05713495001043VYAFUSER™VYAFUSER PUMP KIT US/PR A20898704102024-11-13
05713495000053myBETAappiOS (Mobile App)846010632019-10-07
05713495000060myBETAappAndroid (Mobile App)846010632019-10-07
05713495000015BETACONNECT82289801822898012019-10-07
05713495000084Skytrofa Auto-Injector10022472021-10-22
05713495000039myBETAappWindows Thin Client (Desktop)846010632019-10-07
05713495000046myBETAappMac Thin Client (Desktop)846010632019-10-07

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
57622436104114Glatopaject ®AEROPHARM GmbHKZH2025-08-19
47622436104100Glatopaject ®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