SKYTROFA Auto-Injector

FDA UDI

Class II (US FDA UDI)

by Phillips-Medisize A/S

Identity

Trade Name: SKYTROFA Auto-Injector FDA UDI
Generic Name: Empty self-injector, electronic FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 02 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI: 05713495000121 FDA UDI
FDA Product Code: KZH FDA UDI
GMDN Term: Empty self-injector, electronic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.6920 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

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Serial Number

Yes

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Expiration Date

Yes

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Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 7.09 Inch FDA UDI
Width — 1.46 Inch FDA UDI
Depth — 1.06 Inch FDA UDI
Weight — 150 Gram FDA UDI

Category: Empty self-injector, electronic

SKYTROFA Auto-Injector by Phillips-Medisize A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Empty self-injector, electronic.

Skytrofa Auto-Injector — Phillips-Medisize A/S · 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: Phillips-Medisize A/S

Sources (1)

FDA UDI dddbec02-182b-44b8-bca4-bc3eeaf3a7fd 36 fields · synced May 30, 2026