Freezpen® CL-FPU-35

GUDID 15407008483507

H & O Equipments SA

General cryosurgical system, cryogen gas, mechanical

• Primary Device ID: 15407008483507
• NIH Device Record Key: ae66dd3e-7fdf-41d3-859a-fe3397e3732f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Freezpen®
• Version Model Number: Freezpen 35G
• Catalog Number: CL-FPU-35
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-2482838
• Email: info@clinic6.com
• Phone: 888-2482838
• Email: info@clinic6.com
• Phone: 888-2482838
• Email: info@clinic6.com
• Phone: 888-2482838
• Email: info@clinic6.com
• Phone: 888-2482838
• Email: info@clinic6.com
• Phone: 888-2482838
• Email: info@clinic6.com
• Phone: 888-2482838
• Email: info@clinic6.com
• Phone: 888-2482838
• Email: info@clinic6.com
• Phone: 888-2482838
• Email: info@clinic6.com
• Phone: 888-2482838
• Email: info@clinic6.com
• Phone: 888-2482838
• Email: info@clinic6.com
• Phone: 888-2482838
• Email: info@clinic6.com
• Phone: 888-2482838
• Email: info@clinic6.com
• Phone: 888-2482838
• Email: info@clinic6.com
• Phone: 888-2482838
• Email: info@clinic6.com
• Phone: 888-2482838
• Email: info@clinic6.com
• Phone: 888-2482838
• Email: info@clinic6.com
• Phone: 888-2482838
• Email: info@clinic6.com
• Phone: 888-2482838
• Email: info@clinic6.com
• Phone: 888-2482838
• Email: info@clinic6.com
• Phone: 888-2482838
• Email: info@clinic6.com
• Phone: 888-2482838
• Email: info@clinic6.com
• Phone: 888-2482838
• Email: info@clinic6.com
• Phone: 888-2482838
• Email: info@clinic6.com
• Phone: 888-2482838
• Email: info@clinic6.com
• Phone: 888-2482838
• Email: info@clinic6.com
• Phone: 888-2482838
• Email: info@clinic6.com
• Phone: 888-2482838
• Email: info@clinic6.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	15407008483507 [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: 2020-09-24
• Device Publish Date: 2020-09-16

On-Brand Devices [Freezpen®]

• B386CLFP160: Freezpen 16G
• B386CLFP010: Freezpen 8G
• 25407008484501: 35g cartridges for Freezpen
• 15407008483507: Freezpen 35G
• B386CLN2O8GUNCARTON2: 8g cartridges for Freezpen
• B386CLN2O16GUNCARTON2: 16g cartridges for Freezpen
• 15407008483101: Freezpen 8g
• 25407008484204: 16g cartridges for Freezpen
• 25407008484006: 8g cartridges for Freezpen
• 25407008484303: 16g cartridges for Freezpen
• 25407008484105: 8g cartridges for Freezpen
• 15407008483309: Freezpen 16g
• B386CLFPU180: Freezpen 16G
• B386CLFPU020: Freezpen 8G
• 15407008483514: Freezpen 35g
• 15407008483316: Freezpen 16g
• 15407008483118: Freezpen 8g