CODMAN®

Basic Information

• Brand Name: CODMAN®
• Primary DI: 10381780521730
• Version / Model: 9190001GF
• Catalog Number: 9190001GF
• Company Name: Integra LifeSciences Switzerland Sàrl
• Labeler DUNS: 480186617
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-04-01
• Public Version: 4
• Public Version Date: 2023-04-14
• Public Version Status: Update
• Public Device Record Key: 3f70fdd7-5b02-4d8c-99f6-2395fe0a6ef1

Device Description

CODMAN® Integrated Bipolar Cord and Tubing Set Fixed Leads, Gravity Feed

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• 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
GEI	Electrosurgical, cutting & coagulation & accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61798	Ventricular cerebrospinal fluid drainage catheterization kit	A collection of sterile devices intended for short-term access to the brain ventricles to drain cerebrospinal fluid (CSF), and/or other fluids of similar physical characteristics, as a means of reducing CSF volume and intracranial pressure (ICP). It includes an intracerebral infusion/drainage catheter and devices intended for catheter insertion (e.g. stylet) and CSF collection (e.g., drip chamber, drainage bag, tubing set). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00381780521733	GS1
Primary	10381780521730	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K163106	000

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 50 – 105 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 105 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius