CryoProbe™ S-HO-COPR-01

GUDID B386SHOCOPR010

H & O Equipments SA

General cryosurgical system, cryogen gas, mechanical

• Primary Device ID: B386SHOCOPR010
• NIH Device Record Key: 2e2324c7-bf4d-4c9a-9a7d-a11a0f6d8d3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CryoProbe™
• Version Model Number: CryoProbe|o 2018
• Catalog Number: S-HO-COPR-01
• 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: cryoprobe@ho-equipments.com
• Phone: 888-2482838
• Email: cryoprobe@ho-equipments.com
• Phone: 888-2482838
• Email: cryoprobe@ho-equipments.com
• Phone: 888-2482838
• Email: cryoprobe@ho-equipments.com
• Phone: 888-2482838
• Email: cryoprobe@ho-equipments.com
• Phone: 888-2482838
• Email: cryoprobe@ho-equipments.com
• Phone: 888-2482838
• Email: cryoprobe@ho-equipments.com
• Phone: 888-2482838
• Email: cryoprobe@ho-equipments.com
• Phone: 888-2482838
• Email: cryoprobe@ho-equipments.com
• Phone: 888-2482838
• Email: cryoprobe@ho-equipments.com
• Phone: 888-2482838
• Email: cryoprobe@ho-equipments.com
• Phone: 888-2482838
• Email: cryoprobe@ho-equipments.com
• Phone: 888-2482838
• Email: cryoprobe@ho-equipments.com
• Phone: 888-2482838
• Email: cryoprobe@ho-equipments.com
• Phone: 888-2482838
• Email: cryoprobe@ho-equipments.com
• Phone: 888-2482838
• Email: cryoprobe@ho-equipments.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B386SHOCOPR010 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-06

On-Brand Devices [CryoProbe™]

• B386STOUCH300: CryoProbe|touch
• B386SHOCXPRP020: CryoProbe|xgyn
• B386SHOCXPRP010: CryoProbe|x+ 2018
• B386SHOCOPR010: CryoProbe|o 2018
• B386SHOCBPLUSPR040: CryoProbe |b White
• B386SHOCEPR000: CryoProbe XP
• B386SHOCBPLUSPR050: CryoProbe B+
• 15407008481503: CryoProbe XP
• 15407008481107: CryoProbe X+
• 25407008482507: 23g cartridges for CryoProbe
• 25407008482309: 16g cartridges for CryoProbe
• 25407008482101: 8g cartridges for CryoProbe
• 15407008481404: CryoProbe Touch
• 15407008481305: CryoProbe O
• 15407008481206: CryoProbe B+
• 15407008481008: CryoProbe M
• 15407008481602: CryoProbe XPS
• 15407008481510: CryoProbe XP
• 15407008481312: CryoProbe O+
• 15407008481213: CryoProbe B+
• 15407008481114: CryoProbe X+
• 15407008481022: CryoProbe M