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.

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Primary Device ID00857326005499
NIH Device Record Key206d40bd-5f72-40e8-9037-b6681c23e370
Commercial Distribution StatusIn Commercial Distribution
Brand NameCyclone Sinonasal Suction/Irrigation System
Version Model NumberCC-100
Company DUNS017283879
Company NameENTELLUS MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100857326005499 [Primary]
GS110857326005496 [Package]
Package: [1 Units]
In Commercial Distribution

FDA Product Code

GBPCatheter, Multiple Lumen

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-10
Device Publish Date2020-09-02

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