CODMAN® CERTAS™ Plus

Basic Information

• Brand Name: CODMAN® CERTAS™ Plus
• Primary DI: 10381780532897
• Version / Model: 828852
• Catalog Number: 82-8852
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-30
• Public Version: 4
• Public Version Date: 2023-05-16
• Public Version Status: Update
• Public Device Record Key: fbffdef6-f61b-4eca-8ec1-f8fab7cc18b4

Device Description

CODMAN® CERTAS® Plus Electronic Tool Kit

Device Characteristics

• Single Use: No
• 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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
44856	Cerebrospinal fluid shunt valve programmer	A device intended to noninvasively modify the operating pressure of a programmable, non-active, implanted hydrocephalic valve that will be part of a hydrocephalic shunt system. It is used in neurosurgery for intra- and postoperative treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. It typically includes electronic circuits, a control panel, a programming information display, and transmitter/identification devices (e.g., smart cards). When externally placed on the location of the implanted valve, it is actuated to supply coded magnetic signals to affect mechanical changes to the pressure characteristics of the proprietary implanted valve.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780532897	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K181902	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Waste from Electrical and Electronic Equipment; Handling Environment Atmospheric Pressure in kPa (High) 101.3; Storage Environment Atmospheric Pressure in kPA (High) 101.3
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: Low: 60 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: -30 – 60 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 15 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 15 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -22 – 140 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: -22 – 140 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: -30 – 60 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: Low: 60 KiloPascal