SinuFlow Cannula
NA - 0290100030
Device Description
An atraumatic, non-surgically invasive, hand-operated, single-lumen, rigid or semi-rigid tube designed to be introduced into the sinus cavities, through the nostrils, to function as a conduit for irrigation and aspiration (i.e., capable of both functions) of the sinus cavities during an ENT procedure, typically for clearance. The device may incorporate a handle with a side valve(s)/hole(s) for the control of irrigation/aspiration, and may be provided with a stylet, sheath, and/or connection tubing. This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: True
Sterilization Methods:
- Moist Heat or Steam Sterilization
Product Codes
Code: KAM
Device Name: Cannula, Sinus
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: SU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 878.4800
Third Party Flag: N
Medical Specialty: SU
Device IdentifiersDevice Id: 07613153064749
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A