Codman® CerebroFlo®

Basic Information

• Brand Name: Codman® CerebroFlo®
• Primary DI: 10381780530138
• Version / Model: 37.550.501
• Catalog Number: 37.550.501
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2022-02-25
• Public Version: 5
• Public Version Date: 2023-05-16
• Public Version Status: Update
• Public Device Record Key: 120ed57c-93f2-4068-b7e8-904b6c39370f

Device Description

Codman® CerebroFlo® EVD Catheter Set With Endexo® Technology Contains 5 Sets

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JXG	Shunt, central nervous system and components	Neurology	882.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61399	Intracerebral infusion/drainage catheter, short-term	A flexible tube intended to be surgically inserted through the skull for short-term (= 30 days) subdural access to the brain (e.g., cerebral ventricles, cystic tumours) for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents); it may also be intended for measurement of intracranial pressure (ICP). It may include an attached port/reservoir at its proximal end that is placed subcutaneously to facilitate material infusion/collection, and/or accessory devices intended to facilitate catheter introduction and/or stabilization (e.g., stylet, bolts, drills, catheter holder); it does not include a sensor. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780530138	GS1
Previous	10866614000105	GS1
Package	30381780530132	GS1	CARTON	5	In Commercial Distribution
Unit of Use	00381780530131	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K170599	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	3.3	Millimeter
Length	35	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do Not Use if Package is Damaged