FrostAway™ FROSTAWAYPEN

GUDID 15407008487000

H & O Equipments SA

General cryosurgical system, cryogen gas, mechanical

• Primary Device ID: 15407008487000
• NIH Device Record Key: cec7c13c-c820-4041-a24c-cb2103d0d387
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FrostAway™
• Version Model Number: FrostAway Pen
• Catalog Number: FROSTAWAYPEN
• Company DUNS: 370212933
• Company Name: H & O Equipments SA
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-248-2838
• Email: cryoprobe@ho-equipments.com
• Phone: 1-888-248-2838
• Email: cryoprobe@ho-equipments.com
• Phone: 1-888-248-2838
• Email: cryoprobe@ho-equipments.com
• Phone: 1-888-248-2838
• Email: cryoprobe@ho-equipments.com
• Phone: 1-888-248-2838
• Email: cryoprobe@ho-equipments.com
• Phone: 1-888-248-2838
• Email: cryoprobe@ho-equipments.com
• Phone: 1-888-248-2838
• Email: cryoprobe@ho-equipments.com
• Phone: 1-888-248-2838
• Email: cryoprobe@ho-equipments.com
• Phone: 1-888-248-2838
• Email: cryoprobe@ho-equipments.com
• Phone: 1-888-248-2838
• Email: cryoprobe@ho-equipments.com
• Phone: 1-888-248-2838
• Email: cryoprobe@ho-equipments.com
• Phone: 1-888-248-2838
• Email: cryoprobe@ho-equipments.com
• Phone: 1-888-248-2838
• Email: cryoprobe@ho-equipments.com
• Phone: 1-888-248-2838
• Email: cryoprobe@ho-equipments.com
• Phone: 1-888-248-2838
• Email: cryoprobe@ho-equipments.com
• Phone: 1-888-248-2838
• Email: cryoprobe@ho-equipments.com
• Phone: 1-888-248-2838
• Email: cryoprobe@ho-equipments.com
• Phone: 1-888-248-2838
• Email: cryoprobe@ho-equipments.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	15407008487000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K024009

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: 2025-05-27
• Device Publish Date: 2025-05-19

On-Brand Devices [FrostAway™]

• 05407008487003: FrostAway Pen cartridges
• 15407008487000: FrostAway Pen