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, Manual, Surgical, General Use (MDM) (1) Instrument, Shunt System Implantation (GYK) (1) Instrument, Surgical, Non-Powered (HAO) (1)

Premarket Exempt

No Yes

Clear

Subcutaneous Guidewire - Large - 10866614000198 Catalog Number : 41.240.503

Device Description : The Subcutaneous Guidewire is designed to facilitate the subcutaneous passage of The Subcutaneous Guidewire is designed to facilitate the subcutaneous passage of tubing, suture, ribbons, and/or bands between two skin incisions. It is also designed to facilitate the subcutaneous passage of shunt tubing when implanting a ventricular or lumbar cerebrospinal fluid (CSF) shunting system or externalized CSF drain.

Device Class : 1

Duns Number: 078846878

Premarket Exempt : Yes

Product Code : GYK, MDM, HAO

Prescription Use : Yes

Device Count : 1

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