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

Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece (ERL) (5) Ear, Nose, And Throat Stereotaxic Instrument (PGW) (3) Bur, Ear, Nose And Throat (EQJ) (1) Catheter, Irrigation (GBX) (1)

Premarket Exempt

No Yes

Clear

Shaver System Control Unit - 00850002250152 Catalog Number :

Device Description : The Shaver System Control Unit is a component of the Shaver System. The Shaver The Shaver System Control Unit is a component of the Shaver System. The Shaver System shapes bone and resects soft and hard tissues in the areas of otorhinolaryngology.

Device Class : 2

Duns Number: 017283879

Premarket Exempt : No

Product Code : ERL

Prescription Use : Yes

Device Count : 1

Shaver System Power Cord - 00850002250169 Catalog Number :

Device Description : The Shaver System Power Cord is a component of the Shaver System. The Shaver Sy The Shaver System Power Cord is a component of the Shaver System. The Shaver System shapes bone and resects soft and hard tissues in the areas of otorhinolaryngology.

Device Class : 2

Duns Number: 017283879

Premarket Exempt : No

Product Code : ERL

Prescription Use : Yes

Device Count : 1

Shaver System Irrigation Stand - 00850002250176 Catalog Number :

Device Description : The Shaver System Irrigation Stand is a component of the Shaver System. The Sha The Shaver System Irrigation Stand is a component of the Shaver System. The Shaver System shapes bone and resects soft and hard tissues in the areas of otorhinolaryngology.

Device Class : 2

Duns Number: 017283879

Premarket Exempt : No

Product Code : ERL

Prescription Use : Yes

Device Count : 1

Shaver System Irrigation Clips - 00850002250183 Catalog Number :

Device Description : The Shaver System Irrigation Clips are an accessory to the Shaver System Irrigat The Shaver System Irrigation Clips are an accessory to the Shaver System Irrigation Stand. The Shaver System shapes bone and resects soft and hard tissues in the areas of otorhinolaryngology.

Device Class : 1

Duns Number: 017283879

Premarket Exempt : Yes

Product Code : GBX

Prescription Use : Yes

Device Count : 1

Shaver System Cleaning Brush - 00850002250190 Catalog Number :

Device Description : The Shaver System Cleaning Brush is an accessory to the Shaver System. The Shav The Shaver System Cleaning Brush is an accessory to the Shaver System. The Shaver System shapes bone and resects soft and hard tissues in the areas of otorhinolaryngology.

Device Class : 2

Duns Number: 017283879

Premarket Exempt : No

Product Code : ERL

Prescription Use : Yes

Device Count : 1

Shaver Blade Cleaning Brush - 00850002250206 Catalog Number :

Device Description : The Shaver Blade Cleaning Brush is an accessory to the Shaver System. The Shave The Shaver Blade Cleaning Brush is an accessory to the Shaver System. The Shaver System shapes bone and resects soft and hard tissues in the areas of otorhinolaryngology.

Device Class : 2

Duns Number: 017283879

Premarket Exempt : No

Product Code : ERL

Prescription Use : Yes

Device Count : 1

Shaver Blade 2.1mm Reusable Double Serrated Straight - 00850002250213 Catalog Number :

Device Description : The Shaver 2.1mm Reusable Double Serrated Straight Blade is used with the Shaver The Shaver 2.1mm Reusable Double Serrated Straight Blade is used with the Shaver System. The blade is a reusable device supplied sterile and requires reprocessing (cleaning, lubrication and sterilization) after the initial use. The Shaver System shapes bone and resects soft and hard tissues in the areas of otorhinolaryngology.

Device Class : 1

Duns Number: 017283879

Premarket Exempt : Yes

Product Code : EQJ

Prescription Use : Yes

Device Count : 1

TGS Guidewire - 00850002250220 Catalog Number : 8000-060-009

Device Description : The TGS Guidewire is intended as an aid for precisely locating anatomical struct The TGS Guidewire is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The TGS Guidewire is intended to be used with the Stryker ENT Navigation System and the XprESS LoProfile ENT Dilation System.

Device Class :

Duns Number: 017283879

Premarket Exempt : No

Product Code : PGW

Prescription Use : Yes

Device Count : 1

TGS Universal Headrest - 00850002250237 Catalog Number :

Device Description : The TGS Universal Headrest is a component of the TGS Universal Headrest with Mou The TGS Universal Headrest is a component of the TGS Universal Headrest with Mounting Arm. The TGS Universal Headrest with Mounting Arm is an accessory to the Stryker ENT Navigation System and is intended for positioning the Field Generator. It also provides a resting surfaced for the patient to place their head during procedures requiring navigation.

Device Class : 2

Duns Number: 017283879

Premarket Exempt : No

Product Code : PGW

Prescription Use : Yes

Device Count : 1

TGS Universal Headrest Mounting Arm - 00850002250244 Catalog Number :

Device Description : The TGS Universal Mounting Arm is a component of the TGS Universal Headrest with The TGS Universal Mounting Arm is a component of the TGS Universal Headrest with Mounting Arm. The TGS Universal Headrest with Mounting Arm is an accessory to the Stryker ENT Navigation System and is intended for positioning the Field Generator.

Device Class : 2

Duns Number: 017283879

Premarket Exempt : No

Product Code : PGW

Prescription Use : Yes

Device Count : 1

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