Cyclone Sinonasal Suction/Irrigation System

GUDID 00857326005499

The Cyclone Sinonasal Suction/Irrigation System is a sterile, single-use medical device that allows a user to simultaneously irrigate the sinonasal spaces and suction away the effluent. The system includes the Cyclone device, a 30cc syringe and a bending tool.

ENTELLUS MEDICAL, INC.

Surgical/emergency suction cannula, non-illuminating, single-use

• Primary Device ID: 00857326005499
• NIH Device Record Key: 206d40bd-5f72-40e8-9037-b6681c23e370
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cyclone Sinonasal Suction/Irrigation System
• Version Model Number: CC-100
• Company DUNS: 017283879
• Company Name: ENTELLUS MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00857326005499 [Primary]
GS1	10857326005496 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Product Code

• GBP: Catheter, Multiple Lumen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-10
• Device Publish Date: 2020-09-02

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