ARKIS BIOSCIENCES INC.

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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

Instrument, Shunt System Implantation (GYK) (7) Shunt, Central Nervous System And Components (JXG) (2) Instrument, Manual, Surgical, General Use (MDM) (1) Instrument, Surgical, Non-Powered (HAO) (1) Retractor (GAD) (1)

Premarket Exempt

No Yes

Clear

CerebroFlo EVD Catheter Set - 00866614000108 Catalog Number : 37.550.101

Device Description : The CerebroFlo EVD Catheter is a polyurethane catheter for diverting cerebrospin

Device Class : 2

Duns Number: 078846878

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

Galea Elevator - 00866614000115 Catalog Number : 41.312.101

Device Description : The Galea Elevator is a stainless-steel, reusable, manual surgical instrument de

Device Class : 1

Duns Number: 078846878

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

Single Pass Tunneling Guidewire - Large - 00866614000122 Catalog Number : 41.157.103

Device Description : The Single Pass Tunneling Guidewire kit is designed to facilitate the subcutaneo

Device Class : 1

Duns Number: 078846878

Premarket Exempt : Yes

Product Code : GYK

Prescription Use : Yes

Device Count : 1

Single Pass Tunneling Guidewire - Medium - 00866614000139 Catalog Number : 41.157.102

Device Description : The Single Pass Tunneling Guidewire kit is designed to facilitate the subcutaneo

Device Class : 1

Duns Number: 078846878

Premarket Exempt : Yes

Product Code : GYK

Prescription Use : Yes

Device Count : 1

Single Pass Tunneling Guidewire - Small - 00866614000146 Catalog Number : 41.157.101

Device Description : The Single Pass Tunneling Guidewire kit is designed to facilitate the subcutaneo

Device Class : 1

Duns Number: 078846878

Premarket Exempt : Yes

Product Code : GYK

Prescription Use : Yes

Device Count : 1

Precision Tunneler - Small - 00866614000153 Catalog Number : 41.020.501

Device Description : The Arkis Precision Tunneler is designed to facilitate the subcutaneous passage

Device Class : 1

Duns Number: 078846878

Premarket Exempt : Yes

Product Code : GYK

Prescription Use : Yes

Device Count : 1

Precision Tunneler - Medium - 00866614000160 Catalog Number : 41.020.502

Device Description : The Arkis Precision Tunneler is designed to facilitate the subcutaneous passage

Device Class : 1

Duns Number: 078846878

Premarket Exempt : Yes

Product Code : GYK

Prescription Use : Yes

Device Count : 1

Precision Tunneler - Large - 00866614000177 Catalog Number : 41.020.503

Device Description : The Arkis Precision Tunneler is designed to facilitate the subcutaneous passage

Device Class : 1

Duns Number: 078846878

Premarket Exempt : Yes

Product Code : GYK

Prescription Use : Yes

Device Count : 1

CerebroFlo EVD Catheter Set - 10866614000105 Catalog Number : 37.550.501

Device Description : The CerebroFlo EVD Catheter is a polyurethane catheter for diverting cerebrospin

Device Class : 2

Duns Number: 078846878

Premarket Exempt : No

Product Code : JXG

Prescription Use : Yes

Device Count : 1

Subcutaneous Guidewire - Medium - 10866614000181 Catalog Number : 41.240.502

Device Description : The Subcutaneous Guidewire is designed to facilitate the subcutaneous passage of

Device Class : 1

Duns Number: 078846878

Premarket Exempt : Yes

Product Code : MDM, HAO, GYK

Prescription Use : Yes

Device Count : 1

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