Freezpen®

FDA UDI

Class II (US FDA UDI)

by H & O Equipments SA

Identity

Trade Name: Freezpen® FDA UDI
Generic Name: Nitrous oxide gas cartridge FDA UDI
Model / Reference: Freezpen 16G FDA UDI

Identifiers

Catalog Number: CL-FP-16 FDA UDI
Primary DI / UDI-DI: B386CLFP160 FDA UDI
510(k) Number: K024009 FDA UDI
FDA Product Code: GEH FDA UDI
GMDN Term: Nitrous oxide gas cartridge FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4350 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

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Nitrous oxide gas cartridge

Freezpen® by H & O Equipments SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nitrous oxide gas cartridge.

ClariFix — Arrinex, Inc. · Class II
ClariFix — Stryker Corp. · Class II
ClariFix — Arrinex, Inc. · Class II
CryoProbe — H & O Equipments SA · Class II
Freezpen® — H & O Equipments SA · Class II
FrostAway™ — H & O Equipments SA · Class II
Freezpen — H & O Equipments SA · Class II
CryoProbe™ — H & O Equipments SA · Class II

Cleared under the same submission

K024009 also covers:

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: H & O Equipments SA

Sources (1)

FDA UDI 4a564a08-d611-48f1-8884-affef980c8dd 35 fields · synced Jun 8, 2026