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
- 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 IdentifiersDevice 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