CLARUS MEDICAL, LLC

Address:13355 10th Ave N Ste 110,Minneapolis,MN,55441,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

Accessories, Cleaning Brushes, For Endoscope (MNL) (5) Endoscope, Neurological (GWG) (5)

Premarket Exempt

No Yes

Clear

ChannelScope - 00810004820654 Catalog Number : 2233-005

Device Description : ChannelScope, Short, 13.0cm Working Length

Device Class : 2

Duns Number: 010316284

Premarket Exempt : No

Product Code : GWG

Prescription Use : Yes

Device Count : 1

ChannelScope - 00810004820661 Catalog Number : 2233-002

Device Description : ChannelScope, Long, 21.6cm Working Length

Device Class : 2

Duns Number: 010316284

Premarket Exempt : No

Product Code : GWG

Prescription Use : Yes

Device Count : 1

NeuroPEN - 00810004820678 Catalog Number : 2120-025

Device Description : NeuroPEN, Short, 15.5cm Working Length

Device Class : 2

Duns Number: 010316284

Premarket Exempt : No

Product Code : GWG

Prescription Use : Yes

Device Count : 1

Peelaway Introducer Sheath, 14Fr - 00810004820746 Catalog Number : 1305-014

Device Description : Peelaway Introducer Sheath, 14 French, Dome Tipped

Device Class : 2

Duns Number: 010316284

Premarket Exempt : No

Product Code : GWG

Prescription Use : Yes

Device Count : 1

ChannelScope, Long, 10K - 00810004820937 Catalog Number : 2232-002

Device Description : ChannelScope, 10K Pixels, Long, 21.6cm Working Length

Device Class : 2

Duns Number: 010316284

Premarket Exempt : No

Product Code : GWG

Prescription Use : Yes

Device Count : 1

Clarus Digital Inspection Scope, 1.9mm OD - 10810004820002 Catalog Number : CD2-1100

Device Description : The Clarus Inspection Scope is a device with a flexible working length intended

Device Class : 1

Duns Number: 010316284

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : No

Device Count : 1

Clarus Inspection Scope, Long - 10810004820026 Catalog Number : C2-950

Device Description : The Clarus Inspection Scope is a device with a flexible working length intended

Device Class : 1

Duns Number: 010316284

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : No

Device Count : 1

Clarus Inspection Scope, Mini - 10810004820033 Catalog Number : C1-800

Device Description : The Clarus Inspection Scope is a device with a flexible working length intended

Device Class : 1

Duns Number: 010316284

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : No

Device Count : 1

Clarus Digital Inspection Scope, Long - 10810004820552 Catalog Number :

Device Description : The Clarus Inspection Scope is a device with a flexible working length intended

Device Class : 1

Duns Number: 010316284

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : No

Device Count : 1

Clarus Inspection Scope, Mini, Short - 10810004820569 Catalog Number : C1-350

Device Description : The Clarus Inspection Scope is a device with a flexible working length intended

Device Class : 1

Duns Number: 010316284

Premarket Exempt : Yes

Product Code : MNL

Prescription Use : No

Device Count : 1

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