Hermetic™ External Drainage Lumbar Catheter

Basic Information

• Brand Name: Hermetic™ External Drainage Lumbar Catheter
• Primary DI: 10381780072553
• Version / Model: SP0224
• Catalog Number: SP0224
• Company Name: Integra Lifesciences Corporation
• Labeler DUNS: 083171244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-22
• Public Version: 5
• Public Version Date: 2020-12-15
• Public Version Status: Update
• Public Device Record Key: 3bed075f-6137-425c-9ff2-09939071d398

Device Description

LUMBAR CATHETER CLOSED TIP The 80cm barium impregnated silicone lumbar catheter has a closed radiopaque tip and is supplied with a Teflon coated stainless steel guide wire and end stop for assisting catheter placement. Approximately 18mm of the tip is multi-perforated to help improve flow and decrease the possibility of obstruction. Designed for diverting fluid from the lumbar subarachnoid space, the catheter can be inserted with a Tuohy needle using percutaneous techniques. The external portion of the catheter is secured to the subcutaneous tissue in the lumbar area by the suture collar. A 14-guage thin wall Tuohy needle with obturator, guide wire, and 22-gauge blunt needle are included. A female luer adapter and train relief tubing is also included. Two suture collars may be wrapped around the catheter and may be anchored in place with a suture.

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: No
• 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: No
• 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
61797	Lumbar cerebrospinal fluid drainage catheterization kit	A collection of sterile devices intended for short-term percutaneous access to the subarachnoid (intrathecal) or epidural space of the lumbar spinal column to drain cerebrospinal fluid (CSF), and/or other fluids of similar physical characteristics, as a means of reducing CSF volume and intracranial pressure (ICP). It includes a spinal infusion/drainage catheter and devices intended for catheter insertion (e.g. Tuohy needle, suture, guidewire) and CSF collection (e.g., drip chamber, drainage bag, tubing set, filter). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780072553	GS1
Secondary	M269SP02241	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K970658	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			80cm Hermetic Lumbar Catheter Closed Tip (0.7mm I.D. x 1.5mm O.D.)