CODMAN® CERTAS® Plus

Basic Information

• Brand Name: CODMAN® CERTAS® Plus
• Primary DI: 10381780535805
• Version / Model: 828813PL
• Catalog Number: 82-8813PL
• Company Name: Integra LifeSciences Switzerland Sàrl
• Labeler DUNS: 480186617
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-20
• Public Version: 4
• Public Version Date: 2025-10-17
• Public Version Status: Update
• Public Device Record Key: ab32792b-bc17-48e2-a6e1-7184b8e86c16

Device Description

CODMAN® CERTAS® Plus Programmable Valve Inline Small Valve with Accessories and Unitized BACTISEAL® Catheter Includes: BACTISEAL Ventricular Catheter, BACTISEAL Unitized Distal Catheter, Priming Adapter, Right Angle Adapter and Information Manual

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• 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
JXG	Shunt, central nervous system and components	Neurology	882.5550	2
HCA	CATHETER, VENTRICULAR	Neurology	882.4100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35965	Cerebrospinal fluid shunt valve	An implantable device intended to function as part of a lumboperitoneal, ventriculoperitoneal or ventriculoatrial shunt to regulate the pressure and flow level of cerebrospinal fluid (CSF) from the lumbar spine or brain to the peritoneum/heart right atrium in the management of increased intracranial pressure (e.g., caused by hydrocephalus). It consists of a mechanical valve with catheter connections and is made of synthetic polymer and/or metallic materials; it does not incorporate a port or reservoir. It typically opens at a pre-set pressure and may be non-invasively adjusted using a dedicated programmer.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780535805	GS1
Previous	10381780529231	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if package is damaged, Keep away from sunlight
• Type: Storage Environment Temperature
• Temperature Range: 2 – 27 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 2 – 27 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 36 – 81 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 36 – 81 Degrees Fahrenheit