Compound W® N/A

GUDID 00075137110854

COMPOUND W® DUAL POWER (2-in-1 Treatment Kit for Large Warts)

MEDTECH PRODUCTS INC.

Wart-removal cryogenic kit

• Primary Device ID: 00075137110854
• NIH Device Record Key: bbf2776d-266a-41d6-bb3c-25f7cf9c8248
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Compound W®
• Version Model Number: CW067601; CW067201; CW067202; CW068101 (First Aid)
• 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: true
• 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.xx
• Phone: 1-800-443-4908
• Email: xx@xx.xx
• Phone: 1-800-443-4908
• Email: xx@xx.xx
• Phone: 1-800-443-4908
• Email: xx@xx.xx
• Phone: 1-800-443-4908
• Email: xx@xx.xx
• Phone: 1-800-443-4908
• Email: xx@xx.xx
• Phone: 1-800-443-4908
• Email: xx@xx.xx
• Phone: 1-800-443-4908
• Email: xx@xx.xx
• Phone: 1-800-443-4908
• Email: xx@xx.xx
• Phone: 1-800-443-4908
• Email: xx@xx.xx
• Phone: 1-800-443-4908
• Email: xx@xx.xx
• Phone: 1-800-443-4908
• Email: xx@xx.xx
• Phone: 1-800-443-4908
• Email: xx@xx.xx
• Phone: 1-800-443-4908
• Email: xx@xx.xx
• Phone: 1-800-443-4908
• Email: xx@xx.xx
• Phone: 1-800-443-4908
• Email: xx@xx.xx
• Phone: 1-800-443-4908
• Email: xx@xx.xx
• Phone: 1-800-443-4908
• Email: xx@xx.xx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰ F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰ F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰ F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰ F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰ F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰ F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰ F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰ F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰ F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰ F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰ F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰ F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰ F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰ F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰ F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰ F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰ F (50⁰C). Store at room temperature away from heat.
• Special Storage Condition, Specify: Between 0 and 0 *Protect from sunlight and do not expose to temperatures above 120⁰ F (50⁰C). Store at room temperature away from heat.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00075137110854 [Primary]
GS1	10075137110851 [Package]; Package: shipping case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161294

FDA Product Code

• GEH: Unit, Cryosurgical, Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-09

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• 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