ENTELLUS MEDICAL, INC.

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

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Filters

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

Eustachian Tube Balloon Dilation Device (PNZ) (5) Instrument, Ent Manual Surgical (LRC) (5) Polymer, Ear, Nose And Throat, Synthetic, Absorbable (NHB) (5)

Premarket Exempt

No Yes

Clear

LATERA - 00857037006037 Catalog Number :

Device Description : Latera 20mm Absorbable Nasal Implant System

Device Class : 2

Duns Number: 017283879

Premarket Exempt : No

Product Code : NHB

Prescription Use : Yes

Device Count : 1

LATERA - 00857037006044 Catalog Number :

Device Description : absorbable nasal implant

Device Class :

Duns Number: 017283879

Premarket Exempt : No

Product Code : NHB

Prescription Use : Yes

Device Count : 2

LATERA - 00857037006075 Catalog Number :

Device Description : Latera 24mm Absorbable Nasal Implant System

Device Class : 2

Duns Number: 017283879

Premarket Exempt : No

Product Code : NHB

Prescription Use : Yes

Device Count : 1

LATERA - 00857037006082 Catalog Number :

Device Description : Latera 24mm Absorbable Nasal Implant

Device Class : 2

Duns Number: 017283879

Premarket Exempt : No

Product Code : NHB

Prescription Use : Yes

Device Count : 1

LATERA - 00857037006105 Catalog Number :

Device Description : Latera 24 mm Delivery Device

Device Class : 2

Duns Number: 017283879

Premarket Exempt : No

Product Code : NHB

Prescription Use : Yes

Device Count : 1

XprESS ENT Dilation System - 00857326005000 Catalog Number : LPLF-105

Device Description : XprESS LoProfile 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 - 00857326005017 Catalog Number : LPLF-106

Device Description : XprESS LoProfile 6x20mm 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 - 00857326005024 Catalog Number : LPLF-107

Device Description : XprESS LoProfile 7x20mm 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 - 00857326005031 Catalog Number : LPLF-205

Device Description : XprESS LoProfile 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 - 00857326005048 Catalog Number : LPLF-206

Device Description : XprESS LoProfile 6x8mm ENTDilation System

Device Class :

Duns Number: 017283879

Premarket Exempt : No

Product Code : LRC, PNZ

Prescription Use : Yes

Device Count : 1

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