Skytrofa Auto-Injector

GUDID 05713495000084

Phillips-Medisize A/S

Cartridge-accepting autoinjector, electronic

• Primary Device ID: 05713495000084
• NIH Device Record Key: 30303305-0891-4975-9f3f-2d55c0e2376b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Skytrofa Auto-Injector
• Version Model Number: 1002247
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713495000077 [Primary]
GS1	05713495000084 [Package]; Contains: 05713495000077; Package: [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: 2021-11-01
• Device Publish Date: 2021-10-22

On-Brand Devices [Skytrofa Auto-Injector]

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