CerebroFlo EVD Catheter Set 37.550.501

GUDID 10866614000105

The CerebroFlo EVD Catheter is a polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through the drainage holes near the catheter's tip. The catheter is barium-sulfate impregnated to provide radiopacity. The CerebroFlo EVD Catheter is provided with a Stylette, Trocar, Barbed Leur Connector, Male Leur Cap, and a suture clip.

ARKIS BIOSCIENCES INC.

Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral catheter cranial-fixation kit Intracerebral catheter cranial-fixation kit Intracerebral catheter cranial-fixation kit Intracerebral catheter cranial-fixation kit Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term Intracerebral infusion/drainage catheter, short-term
Primary Device ID10866614000105
NIH Device Record Keyb3a38145-55be-4f7a-a6b1-f4cb46fdd2e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameCerebroFlo EVD Catheter Set
Version Model Number37.550.501
Catalog Number37.550.501
Company DUNS078846878
Company NameARKIS BIOSCIENCES INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Phone+1(844)247-5383
Emailinfo@arkisbiosciences.com
Phone+1(844)247-5383
Emailinfo@arkisbiosciences.com
Phone+1(844)247-5383
Emailinfo@arkisbiosciences.com
Phone+1(844)247-5383
Emailinfo@arkisbiosciences.com
Phone+1(844)247-5383
Emailinfo@arkisbiosciences.com
Phone+1(844)247-5383
Emailinfo@arkisbiosciences.com
Phone+1(844)247-5383
Emailinfo@arkisbiosciences.com
Phone+1(844)247-5383
Emailinfo@arkisbiosciences.com
Phone+1(844)247-5383
Emailinfo@arkisbiosciences.com
Phone+1(844)247-5383
Emailinfo@arkisbiosciences.com
Phone+1(844)247-5383
Emailinfo@arkisbiosciences.com
Phone+1(844)247-5383
Emailinfo@arkisbiosciences.com
Phone+1(844)247-5383
Emailinfo@arkisbiosciences.com
Phone+1(844)247-5383
Emailinfo@arkisbiosciences.com
Phone+1(844)247-5383
Emailinfo@arkisbiosciences.com
Phone+1(844)247-5383
Emailinfo@arkisbiosciences.com
Phone+1(844)247-5383
Emailinfo@arkisbiosciences.com
Phone+1(844)247-5383
Emailinfo@arkisbiosciences.com
Phone+1(844)247-5383
Emailinfo@arkisbiosciences.com
Phone+1(844)247-5383
Emailinfo@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

Device Dimensions

Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter
Length35 Centimeter
Outer Diameter3.3 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110866614000105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JXGShunt, Central Nervous System And Components

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-01
Device Publish Date2019-10-24

On-Brand Devices [CerebroFlo EVD Catheter Set]

00866614000108The CerebroFlo EVD Catheter is a polyurethane catheter for diverting cerebrospinal fluid (CSF) f
10866614000105The CerebroFlo EVD Catheter is a polyurethane catheter for diverting cerebrospinal fluid (CSF) f
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