SKYTROFA Auto-Injector

GUDID 05713495000138

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.

Phillips-Medisize A/S

Empty self-injector, electronic

• Primary Device ID: 05713495000138
• NIH Device Record Key: dddbec02-182b-44b8-bca4-bc3eeaf3a7fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SKYTROFA Auto-Injector
• Version Model Number: 02
• Company DUNS: 306047440
• Company Name: Phillips-Medisize A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-844-442-7236
• Email: JDW@AscendisPharma.com
• Phone: 1-844-442-7236
• Email: JDW@AscendisPharma.com
• Phone: 1-844-442-7236
• Email: JDW@AscendisPharma.com
• Phone: 1-844-442-7236
• Email: JDW@AscendisPharma.com
• Phone: 1-844-442-7236
• Email: JDW@AscendisPharma.com
• Phone: 1-844-442-7236
• Email: JDW@AscendisPharma.com
• Phone: 1-844-442-7236
• Email: JDW@AscendisPharma.com
• Phone: 1-844-442-7236
• Email: JDW@AscendisPharma.com
• Phone: 1-844-442-7236
• Email: JDW@AscendisPharma.com
• Phone: 1-844-442-7236
• Email: JDW@AscendisPharma.com
• Phone: 1-844-442-7236
• Email: JDW@AscendisPharma.com
• Phone: 1-844-442-7236
• Email: JDW@AscendisPharma.com
• Phone: 1-844-442-7236
• Email: JDW@AscendisPharma.com

Device Dimensions

• Length: 7.09 Inch
• Width: 1.46 Inch
• Depth: 1.06 Inch
• Weight: 150 Gram
• Length: 7.09 Inch
• Width: 1.46 Inch
• Depth: 1.06 Inch
• Weight: 150 Gram
• Length: 7.09 Inch
• Width: 1.46 Inch
• Depth: 1.06 Inch
• Weight: 150 Gram
• Length: 7.09 Inch
• Width: 1.46 Inch
• Depth: 1.06 Inch
• Weight: 150 Gram
• Length: 7.09 Inch
• Width: 1.46 Inch
• Depth: 1.06 Inch
• Weight: 150 Gram
• Length: 7.09 Inch
• Width: 1.46 Inch
• Depth: 1.06 Inch
• Weight: 150 Gram
• Length: 7.09 Inch
• Width: 1.46 Inch
• Depth: 1.06 Inch
• Weight: 150 Gram
• Length: 7.09 Inch
• Width: 1.46 Inch
• Depth: 1.06 Inch
• Weight: 150 Gram
• Length: 7.09 Inch
• Width: 1.46 Inch
• Depth: 1.06 Inch
• Weight: 150 Gram
• Length: 7.09 Inch
• Width: 1.46 Inch
• Depth: 1.06 Inch
• Weight: 150 Gram
• Length: 7.09 Inch
• Width: 1.46 Inch
• Depth: 1.06 Inch
• Weight: 150 Gram
• Length: 7.09 Inch
• Width: 1.46 Inch
• Depth: 1.06 Inch
• Weight: 150 Gram
• Length: 7.09 Inch
• Width: 1.46 Inch
• Depth: 1.06 Inch
• Weight: 150 Gram

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713495000114 [Direct Marking]
GS1	05713495000121 [Primary]
GS1	05713495000138 [Package]; Contains: 05713495000121; Package: Carton Box [10 Units]; In Commercial Distribution

FDA Product Code

• KZH: Introducer, Syringe Needle

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-28
• Device Publish Date: 2025-08-20

On-Brand Devices [SKYTROFA Auto-Injector]

• 05713495000084: 1002247
• 05713495000138: The SKYTROFA Auto-Injector is intended to automate the reconstitution (mixing) and subcutaneous