Accurett S-CO2-16G-BOX

GUDID B386SCO216GCARTON2

H & O Equipments SA

Carbon dioxide cartridge, non-sterile

• Primary Device ID: B386SCO216GCARTON2
• NIH Device Record Key: 3b14a45b-92d5-46db-bd88-bef5c19b7a5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accurett
• Version Model Number: 16g CO2 cartridges
• Catalog Number: S-CO2-16G-BOX
• Company DUNS: 370212933
• Company Name: H & O Equipments SA
• Device Count: 6
• 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@accurett.com
• Phone: 844-2671550
• Email: info@accurett.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B386SCO216GBOX0 [Unit of Use]
HIBCC	B386SCO216GBOX1 [Primary]
HIBCC	B386SCO216GCARTON2 [Package]; Contains: B386SCO216GBOX1; Package: [12 Units]; In Commercial Distribution

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: 2016-09-24

On-Brand Devices [Accurett]

• B386SCO216GCARTON2: 16g CO2 cartridges
• B386SACT100: Accurett