Compound W®

GUDID 00075137108257

Accu-Freeze® Freeze Off® Advanced Wart Removal System

MEDTECH PRODUCTS INC.

Wart-removal cryogenic kit

• Primary Device ID: 00075137108257
• NIH Device Record Key: 77d035c2-7d76-4987-86ac-25d0f2b726e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Compound W®
• Version Model Number: CW044201, CW044104, CW044601
• 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.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

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00075137108257 [Primary]
GS1	10075137108254 [Package]; Contains: 20075137108251; Package: shipping case [2 Units]; In Commercial Distribution
GS1	20075137108251 [Package]; Package: inner pack DI [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140314

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: 2016-09-16

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• 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