MiniFESS Light Seeker IS-100

GUDID 00857326005154

The MiniFESS Light Seeker is a fiber optic based, manually operated, reusable, sinus seeker that emits light from the distal end. It is used during sinus procedures to illuminate anatomy and confirm the location of the paranasal sinuses using the trans-nasal approach.

ENTELLUS MEDICAL, INC.

Paranasal sinus probe Paranasal sinus probe Paranasal sinus probe Paranasal sinus probe Paranasal sinus probe Paranasal sinus probe Paranasal sinus probe Paranasal sinus probe Paranasal sinus probe Paranasal sinus probe Paranasal sinus probe Paranasal sinus probe Paranasal sinus probe Paranasal sinus probe ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator ENT transilluminator

Primary Device ID	00857326005154
NIH Device Record Key	241cbf8f-f14f-479a-b728-059cc686c9b9
Commercial Distribution Status	In Commercial Distribution
Brand Name	MiniFESS Light Seeker
Version Model Number	LP100
Catalog Number	IS-100
Company DUNS	017283879
Company Name	ENTELLUS MEDICAL, 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	false
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	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857326005154 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K133563

FDA Product Code

LRC	Instrument, Ent Manual Surgical