Single Pass Tunneling Guidewire - Large 41.157.103

GUDID 00866614000122

The Single Pass Tunneling Guidewire kit is designed to facilitate the subcutaneous passage of shunt tubing from a frontal scalp incision, or an incision on the neck, to an incision site on the torso when implanting a ventricular shunting system in patients greater than five (5) years old with a normal skull and normal skin.

ARKIS BIOSCIENCES INC.

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• Primary Device ID: 00866614000122
• NIH Device Record Key: 511f2492-db8f-4120-bded-2ac5d9463362
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single Pass Tunneling Guidewire - Large
• Version Model Number: 41.157.103
• Catalog Number: 41.157.103
• Company DUNS: 078846878
• Company Name: ARKIS BIOSCIENCES INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8442475383
• Email: customerservice@arkisbiosciences.com
• Phone: 8442475383
• Email: customerservice@arkisbiosciences.com
• Phone: 8442475383
• Email: customerservice@arkisbiosciences.com
• Phone: 8442475383
• Email: customerservice@arkisbiosciences.com
• Phone: 8442475383
• Email: customerservice@arkisbiosciences.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com
• Phone: +1(800)654-2873
• Email: custserv@integralife.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866614000122 [Primary]

FDA Product Code

• GYK: Instrument, Shunt System Implantation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-14
• Device Publish Date: 2018-12-14

Devices Manufactured by ARKIS BIOSCIENCES INC.

• 10866614000181 - Subcutaneous Guidewire - Medium: 2022-05-23 The Subcutaneous Guidewire is designed to facilitate the subcutaneous passage of tubing, suture, ribbons, and/or bands between t
• 10866614000198 - Subcutaneous Guidewire - Large: 2022-05-23 The Subcutaneous Guidewire is designed to facilitate the subcutaneous passage of tubing, suture, ribbons, and/or bands between t
• 10866614000105 - CerebroFlo EVD Catheter Set: 2019-11-01 The CerebroFlo EVD Catheter is a polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain
• 00866614000115 - Galea Elevator: 2019-05-03 The Galea Elevator is a stainless-steel, reusable, manual surgical instrument designed to retract and elevate scalp tissue.
• 00866614000122 - Single Pass Tunneling Guidewire - Large: 2019-01-14The Single Pass Tunneling Guidewire kit is designed to facilitate the subcutaneous passage of shunt tubing from a frontal scalp incision, or an incision on the neck, to an incision site on the torso when implanting a ventricular shunting system in patients greater than five (5) years old with a normal skull and normal skin.
• 00866614000122 - Single Pass Tunneling Guidewire - Large: 2019-01-14 The Single Pass Tunneling Guidewire kit is designed to facilitate the subcutaneous passage of shunt tubing from a frontal scalp
• 00866614000139 - Single Pass Tunneling Guidewire - Medium: 2019-01-14 The Single Pass Tunneling Guidewire kit is designed to facilitate the subcutaneous passage of shunt tubing from a frontal scalp
• 00866614000146 - Single Pass Tunneling Guidewire - Small: 2019-01-14 The Single Pass Tunneling Guidewire kit is designed to facilitate the subcutaneous passage of shunt tubing from a frontal scalp
• 00866614000153 - Precision Tunneler - Small: 2019-01-14 The Arkis Precision Tunneler is designed to facilitate the subcutaneous passage of shunt tubing between two skin incisions when