CODMAN® HOLTER®

Basic Information

• Brand Name: CODMAN® HOLTER®
• Primary DI: 10381780518112
• Version / Model: 821697
• Catalog Number: 82-1697
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-28
• Public Version: 6
• Public Version Date: 2023-04-14
• Public Version Status: Update
• Public Device Record Key: d210df83-8039-4fa1-a028-d6122ad2a485

Device Description

CODMAN® HOLTER® In-Line Shunt Filter, Hoffman Design

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: 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

GMDN Terms

Code	Name	Definition	Implantable	Status
15688	Cerebrospinal fluid shunt filter	A sterile implantable device intended to be used with a cerebrospinal fluid (CSF) shunt assembly (e.g., ventriculoperitoneal shunt, lumboperitoneal shunt) for in-line shunt placement to filter particles by size to prevent transmission of cells when draining CSF from the brain. It typically includes a cellulose membrane supported in a stainless steel mesh encased in, e.g., silicone, and has ports for connection to the shunt. It is used when neoplasms are present or suspected in patients who need treatment using a CSF shunt. It may be implanted behind the mastoid air cells to expose its content to radiation when applied.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780518112	GS1

Customer Contacts

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