Skytrofa Auto-Injector

Basic Information

• Brand Name: Skytrofa Auto-Injector
• Primary DI: 05713495000077
• Version / Model: 1002247
• Company Name: Phillips-Medisize A/S
• Labeler DUNS: 306047440
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-22
• Public Version: 1
• Public Version Date: 2021-11-01
• Public Version Status: New
• Public Device Record Key: 30303305-0891-4975-9f3f-2d55c0e2376b

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	Cartridge-accepting autoinjector, electronic	A portable, hand-held, battery-powered device 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 is replaced once the pharmaceutical is exhausted; the needle is replaced for each administration. The device includes an electronic display and may be capable of a variety of dose-recording functions. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05713495000084	GS1		10	In Commercial Distribution
Primary	05713495000077	GS1