ENTELLUS MEDICAL, INC.

Address:3600 Holly Lane North, Suite 40,Plymouth,MN,55447,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Instrument, Ent Manual Surgical (LRC) (10) Eustachian Tube Balloon Dilation Device (PNZ) (7)

Premarket Exempt

No Yes

Clear

XprESS ENT Dilation System - 00857326005055 Catalog Number : JD-106

Device Description : XprESS Pro 6x18mm ENT Dilation System

Device Class :

Duns Number: 017283879

Premarket Exempt : No

Product Code : LRC, PNZ

Prescription Use : Yes

Device Count : 1

XprESS ENT Dilation System - 00857326005062 Catalog Number : JD-107

Device Description : XprESS Pro 7x18mm ENT Dilation System

Device Class : 1

Duns Number: 017283879

Premarket Exempt : No

Product Code : LRC, PNZ

Prescription Use : Yes

Device Count : 1

XprESS ENT Dilation System - 00857326005079 Catalog Number : JD-206

Device Description : XprESS Pro 6x8mm ENT Dilation System

Device Class : 1

Duns Number: 017283879

Premarket Exempt : No

Product Code : LRC, PNZ

Prescription Use : Yes

Device Count : 1

XprESS ENT Dilation System - 00857326005116 Catalog Number : ULF-105

Device Description : XprESS Ultra 5x20mm ENT Dilation System

Device Class :

Duns Number: 017283879

Premarket Exempt : No

Product Code : LRC, PNZ

Prescription Use : Yes

Device Count : 1

XprESS ENT Dilation System - 00857326005123 Catalog Number : ULF-106

Device Description : XprESS Ultra 6x20mm ENT Dilation System

Device Class :

Duns Number: 017283879

Premarket Exempt : No

Product Code : PNZ, LRC

Prescription Use : Yes

Device Count : 1

XprESS ENT Dilation System - 00857326005130 Catalog Number : ULF-205

Device Description : XprESS Ultra 5x8mm ENT Dilation System

Device Class :

Duns Number: 017283879

Premarket Exempt : No

Product Code : LRC, PNZ

Prescription Use : Yes

Device Count : 1

XprESS ENT Dilation System - 00857326005147 Catalog Number : ULF-206

Device Description : XprESS Ultra 6x8mm ENT Dilation System

Device Class :

Duns Number: 017283879

Premarket Exempt : No

Product Code : LRC, PNZ

Prescription Use : Yes

Device Count : 1

MiniFESS Light Seeker - 00857326005154 Catalog Number : IS-100

Device Description : The MiniFESS Light Seeker is a fiber optic based, manually operated, reusable, s 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.

Device Class : 1

Duns Number: 017283879

Premarket Exempt : No

Product Code : LRC

Prescription Use : Yes

Device Count : 1

MiniFess Maxilary Seeker 120 Degree - 00857326005185 Catalog Number :

Device Description : The MiniFESS Maxillary Seeker is a reusable, stainless steel surgical instrument The MiniFESS Maxillary Seeker is a reusable, stainless steel surgical instrument used to probe within the sinuses using a trans-nasal approach. The seeker has a 120 degree bend.

Device Class : 1

Duns Number: 017283879

Premarket Exempt : Yes

Product Code : LRC

Prescription Use : Yes

Device Count : 1

MiniFess Maxilary Seeker 135 Degree - 00857326005192 Catalog Number :

Device Class : 1

Duns Number: 017283879

Premarket Exempt : Yes

Product Code : LRC

Prescription Use : Yes

Device Count : 1

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