Subcutaneous Guidewire - Large 41.240.503

GUDID 10866614000198

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.

ARKIS BIOSCIENCES INC.

Subcutaneous tunneller, single-use
Primary Device ID10866614000198
NIH Device Record Key3396cff5-f0c8-4809-8482-bc8ed008f601
Commercial Distribution StatusIn Commercial Distribution
Brand NameSubcutaneous Guidewire - Large
Version Model Number41.240.503
Catalog Number41.240.503
Company DUNS078846878
Company NameARKIS BIOSCIENCES INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8442475383
Emailcustomerservice@arkisbiosciences.com
Phone8442475383
Emailcustomerservice@arkisbiosciences.com
Phone8442475383
Emailcustomerservice@arkisbiosciences.com
Phone8442475383
Emailcustomerservice@arkisbiosciences.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com
Phone+1(800)654-2873
Emailcustserv@integralife.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110866614000198 [Primary]

FDA Product Code

GYKInstrument, Shunt System Implantation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-05-23
Device Publish Date2018-12-14

Devices Manufactured by ARKIS BIOSCIENCES INC.

10866614000181 - Subcutaneous Guidewire - Medium2022-05-23 The Subcutaneous Guidewire is designed to facilitate the subcutaneous passage of tubing, suture, ribbons, and/or bands between t
10866614000198 - Subcutaneous Guidewire - Large2022-05-23The 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.
10866614000198 - Subcutaneous Guidewire - Large2022-05-23 The Subcutaneous Guidewire is designed to facilitate the subcutaneous passage of tubing, suture, ribbons, and/or bands between t
10866614000105 - CerebroFlo EVD Catheter Set2019-11-01 The CerebroFlo EVD Catheter is a polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain
00866614000115 - Galea Elevator2019-05-03 The Galea Elevator is a stainless-steel, reusable, manual surgical instrument designed to retract and elevate scalp tissue.
00866614000122 - Single Pass Tunneling Guidewire - Large2019-01-14 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 - Medium2019-01-14 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 - Small2019-01-14 The Single Pass Tunneling Guidewire kit is designed to facilitate the subcutaneous passage of shunt tubing from a frontal scalp
00866614000153 - Precision Tunneler - Small2019-01-14 The Arkis Precision Tunneler is designed to facilitate the subcutaneous passage of shunt tubing between two skin incisions when

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