- Physicians Office Resource

Compound W® Nitrofreeze™ Nitrous Oxide Wart Removal System
Compound W® - CWUS004502, CWUS004103, CWUS004602

Device Description

A collection of devices designed to apply cold from a liquid/gaseous refrigerant (cryogen) to a common or plantar (sole of foot) wart for its removal. The collection typically includes a pressurized cannister with a cryogenic mixture (e.g., liquid dimethyl ether and propane), disposable applicators, a reusable activator that releases the cryogen into the applicators, and cushions; it may also include a liquid wart remover (e.g., salicylic acid) for post-cryo treatment. It is normally available [non-prescription] over-the-counter (OTC). This is a reusable device.

Environmental Conditions

Special Storage Condition, Specify

Protect from sunlight Do not expose to temps above 50C(100F) before first use or 35C(95F) after 1st use. Exposure to temps >35C(95F) will activate safety feature disabling the device. Store @room temp

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: GEH

Device Name: Unit, Cryosurgical, Accessories

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 878.4350

Third Party Flag: Y

Medical Specialty: SU

Device Identifiers

Device Id: 00075137000032

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

Device Id: 10075137000039

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00075137000032

Package Quantity: 6

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: shipping carton

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