Freezpen® CL-N2O-16G-UNBOX

GUDID B386CLN2O16GUNCARTON2

H & O Equipments SA

General cryosurgical system, cryogen gas, mechanical

• Primary Device ID: B386CLN2O16GUNCARTON2
• NIH Device Record Key: 174a4640-a2d5-4c97-8761-02f0e73fbd6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Freezpen®
• Version Model Number: 16g cartridges for Freezpen
• Catalog Number: CL-N2O-16G-UNBOX
• Company DUNS: 370212933
• Company Name: H & O Equipments SA
• Device Count: 12
• 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: true
• Lot Batch: true
• Serial Number: false
• 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: 844-2671550
• Email: info@clinic6.com
• Phone: 844-2671550
• Email: info@clinic6.com
• Phone: 844-2671550
• Email: info@clinic6.com
• Phone: 844-2671550
• Email: info@clinic6.com
• Phone: 844-2671550
• Email: info@clinic6.com
• Phone: 844-2671550
• Email: info@clinic6.com
• Phone: 844-2671550
• Email: info@clinic6.com
• Phone: 844-2671550
• Email: info@clinic6.com
• Phone: 844-2671550
• Email: info@clinic6.com
• Phone: 844-2671550
• Email: info@clinic6.com
• Phone: 844-2671550
• Email: info@clinic6.com
• Phone: 844-2671550
• Email: info@clinic6.com
• Phone: 844-2671550
• Email: info@clinic6.com
• Phone: 844-2671550
• Email: info@clinic6.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B386CLN2O16GUNBOX0 [Unit of Use]
HIBCC	B386CLN2O16GUNBOX1 [Primary]
HIBCC	B386CLN2O16GUNCARTON2 [Package]; Contains: B386CLN2O16GUNBOX1; Package: [12 Units]; In Commercial Distribution

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-04-07
• Device Publish Date: 2019-05-15

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