CereLink™

Basic Information

• Brand Name: CereLink™
• Primary DI: 10381780520665
• Version / Model: 826845
• Catalog Number: 82-6845
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-01
• Public Version: 8
• Public Version Date: 2023-04-14
• Public Version Status: Update
• Public Device Record Key: 824df48a-9347-404e-8467-a9f5a052aa14

Device Description

CereLink™ ICP Extension Cable

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
GWM	Device, monitoring, intracranial pressure	Neurology	882.1620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61435	Intracranial/compartmental-pressure monitor calibrator/cable	An electronic device intended to generate a reference baseline for the standardization of readings of intracranial pressure (ICP) and/or pressure in a muscle compartment, and to transfer the readings from a catheter (i.e., intracerebral sensor or compartmental-pressure catheter) to a pressure monitor. It consists of a small unit with input and output cables to make electrical connections between a catheter connection cable and the patient monitor. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780520665	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K183406	000
K210993	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Waste Electrical and Electronic Equipment
• Type: Storage Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 32 – 122 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 32 – 122 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 15 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 15 – 85 Percent (%) Relative Humidity