Skyrizi

FDA UDI

Class II (US FDA UDI)

by Abbvie Inc.

Identity

Trade Name: Skyrizi FDA UDI
Generic Name: Subcutaneous self-injection aid FDA UDI
Device Name: The 2.4mL Skyrizi On-Body Injector is designed to be used in conjunction with a pre-filled cartridge assembly containing a 360mg/2.4mL dose of risankizumab-rzaa drug product. The single use device is designed for subcutaneous injection. The device is pre-sterilized and pre-programmed. The device is co-packaged with the drug product and is not marketed separately. FDA UDI
Model / Reference: 19558595 FDA UDI
Description: The 2.4mL Skyrizi On-Body Injector is designed to be used in conjunction with a pre-filled cartridge assembly containing a 360mg/2.4mL dose of risankizumab-rzaa drug product. The single use device is designed for subcutaneous injection. The device is pre-sterilized and pre-programmed. The device is co-packaged with the drug product and is not marketed separately. FDA UDI

Identifiers

Primary DI / UDI-DI: 48054083023234 FDA UDI
FDA Product Code: QLF FDA UDI
GMDN Term: Subcutaneous self-injection aid FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5860 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Width — 41 Millimeter FDA UDI
Length — 85 Millimeter FDA UDI
Height — 22.5 Millimeter FDA UDI

Category: Subcutaneous self-injection aid

Skyrizi by Abbvie Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Subcutaneous self-injection aid.

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Skyrizi — ABBVIE INC. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Abbvie Inc.

Sources (1)

FDA UDI 0cfc8038-5ad4-4478-a401-d419fc8450e7 35 fields · synced May 29, 2026