SKYTROFA Auto-Injector

Basic Information

• Brand Name: SKYTROFA Auto-Injector
• Primary DI: 05713495000121
• Version / Model: 02
• Company Name: Phillips-Medisize A/S
• Labeler DUNS: 306047440
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-20
• Public Version: 1
• Public Version Date: 2025-08-28
• Public Version Status: New
• Public Device Record Key: dddbec02-182b-44b8-bca4-bc3eeaf3a7fd

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KZH	Introducer, Syringe Needle	General Hospital	880.6920	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45819	Empty self-injector, electronic	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05713495000138	GS1	Carton Box	10	In Commercial Distribution
Primary	05713495000121	GS1
Direct Marking	05713495000114	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	7.09	Inch
Width	1.46	Inch
Depth	1.06	Inch
Weight	150	Gram

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 14 – 104 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal