Cyst Puncture Catheter

Basic Information

• Brand Name: Cyst Puncture Catheter
• Primary DI: 10381780035787
• Version / Model: 9ME617
• Catalog Number: 9ME617
• Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
• Labeler DUNS: 531408342
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-01
• Public Version: 4
• Public Version Date: 2018-07-13
• Public Version Status: Update
• Public Device Record Key: 5e4dcf14-a405-42f3-be15-c539640bd600
• Distribution End Date: 2018-07-03

Device Description

The Cyst Puncture Catheter is a 25 cm long, radiopaque silicone elastomer catheter with a tapered end terminating in a tip with a hole. The catheter features radiopaque length markings at 5, 10 and 15 cm from the tip. The catheter has 4 drainage holes, 180 degrees apart. The proximity of the holes near the tip ensures that the holes will not extend outside small cysts. Each catheter is supplied with 2 stylets: a blunt-ended stylet and a sharp-ended stylet.

Device Characteristics

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

GMDN Terms

Code	Name	Definition	Implantable	Status
61376	Intracerebral infusion/drainage catheter, long-term	A sterile, flexible tube intended to be surgically inserted through the skull for long-term (> 30 days) subdural access to the brain (e.g., cerebral ventricles, cystic tumours) for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents); it is typically used for measurement of intracranial pressure (ICP) and as part of a shunt system. It may include an attached port/reservoir at its proximal end that is placed subcutaneously to facilitate material infusion/collection, and/or accessory devices intended to facilitate catheter introduction and/or stabilization (e.g., stylet, catheter holder); it does not include a sensor. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780035787	GS1
Secondary	M2729ME6171	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K955265	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			25cm Length x 2.7mm O.D. x 1.4mm I.D. (F8)