ClariFix CFX-1002

GUDID 00868438000258

Cryogen Canister

ARRINEX, INC.

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• Primary Device ID: 00868438000258
• NIH Device Record Key: 00c9278b-2a74-4d3b-8fd1-477df63d1fe1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClariFix
• Version Model Number: CFX-1002
• Catalog Number: CFX-1002
• Company DUNS: 079807364
• Company Name: ARRINEX, INC.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868438000258 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190356

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: 2019-12-10
• Device Publish Date: 2019-12-02

On-Brand Devices [ClariFix]

• 00868438000227: Cryogen Canister, 10ml
• 00868438000210: Cryogen Canister, 21ml
• 00868438000203: Cryotherapy Device
• 00868438000258: Cryogen Canister
• 00868438000234: Cryotherapy System