Acurrett® S-ACT-8

GUDID B386SACT80

H & O Equipments SA

General cryosurgical system, cryogen gas, mechanical

• Primary Device ID: B386SACT80
• NIH Device Record Key: 43c2509b-275b-4644-95b8-4d9a1c863e23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acurrett®
• Version Model Number: Accurett 8G
• Catalog Number: S-ACT-8
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B386SACT80 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161615

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

Devices Manufactured by H & O Equipments SA

• 15407008481022 - CryoProbe™: 2023-03-20
• 15407008481114 - CryoProbe™: 2023-03-20
• 15407008481213 - CryoProbe™: 2023-03-20
• 15407008481312 - CryoProbe™: 2023-03-20
• 15407008481510 - CryoProbe™: 2023-03-20
• 15407008483118 - Freezpen®: 2023-03-20
• 15407008483316 - Freezpen®: 2023-03-20
• 15407008483514 - Freezpen®: 2023-03-20