Compound W® N/A

GUDID 00075137000032

Compound W® Nitrofreeze™ Nitrous Oxide Wart Removal System

MEDTECH PRODUCTS INC.

Wart-removal cryogenic kit

• Primary Device ID: 00075137000032
• NIH Device Record Key: fcd4641a-9553-4e3a-b9e2-7b1bd4324484
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Compound W®
• Version Model Number: CWUS004502, CWUS004103, CWUS004602
• Catalog Number: N/A
• Company DUNS: 060272465
• Company Name: MEDTECH PRODUCTS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-443-4908
• Email: xx@xx.xxx
• Phone: 1-800-443-4908
• Email: xx@xx.xxx
• Phone: 1-800-443-4908
• Email: xx@xx.xxx
• Phone: 1-800-443-4908
• Email: xx@xx.xxx
• Phone: 1-800-443-4908
• Email: xx@xx.xxx
• Phone: 1-800-443-4908
• Email: xx@xx.xxx
• Phone: 1-800-443-4908
• Email: xx@xx.xxx
• Phone: 1-800-443-4908
• Email: xx@xx.xxx
• Phone: 1-800-443-4908
• Email: xx@xx.xxx
• Phone: 1-800-443-4908
• Email: xx@xx.xxx
• Phone: 1-800-443-4908
• Email: xx@xx.xxx
• Phone: 1-800-443-4908
• Email: xx@xx.xxx
• Phone: 1-800-443-4908
• Email: xx@xx.xxx
• Phone: 1-800-443-4908
• Email: xx@xx.xxx
• Phone: 1-800-443-4908
• Email: xx@xx.xxx
• Phone: 1-800-443-4908
• Email: xx@xx.xxx
• Phone: 1-800-443-4908
• Email: xx@xx.xxx
• Phone: 1-800-443-4908
• Email: xx@xx.xxx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *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
• Special Storage Condition, Specify: Between 0 and 0 *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
• Special Storage Condition, Specify: Between 0 and 0 *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
• Special Storage Condition, Specify: Between 0 and 0 *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
• Special Storage Condition, Specify: Between 0 and 0 *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
• Special Storage Condition, Specify: Between 0 and 0 *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
• Special Storage Condition, Specify: Between 0 and 0 *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
• Special Storage Condition, Specify: Between 0 and 0 *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
• Special Storage Condition, Specify: Between 0 and 0 *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
• Special Storage Condition, Specify: Between 0 and 0 *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
• Special Storage Condition, Specify: Between 0 and 0 *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
• Special Storage Condition, Specify: Between 0 and 0 *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
• Special Storage Condition, Specify: Between 0 and 0 *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
• Special Storage Condition, Specify: Between 0 and 0 *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
• Special Storage Condition, Specify: Between 0 and 0 *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
• Special Storage Condition, Specify: Between 0 and 0 *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
• Special Storage Condition, Specify: Between 0 and 0 *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
• Special Storage Condition, Specify: Between 0 and 0 *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 Identifiers

Device Issuing Agency	Device ID
GS1	00075137000032 [Primary]
GS1	10075137000039 [Package]; Package: shipping carton [6 Units]; In Commercial Distribution

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-17
• Device Publish Date: 2018-11-16

On-Brand Devices [Compound W®]

• 10075137530055: Maximum Freeze Freeze Off® Wart Remover System
• 10075137440347: Maximum Freeze Freeze Off® Plantar Kit Wart Removal System
• 00075137110854: COMPOUND W® DUAL POWER (2-in-1 Treatment Kit for Large Warts)
• 00075137110571: COMPOUND W® COMPLETE WART KIT Maximum Freeze Plantar and Stubborn Warts
• 00075137108257: Accu-Freeze® Freeze Off® Advanced Wart Removal System
• 00075137000032: Compound W® Nitrofreeze™ Nitrous Oxide Wart Removal System
• 10075137000145: Compound W® Nitrofreeze™ Nitrous Oxide Wart Removal System - yellow carton secondary sku