Integra®

Basic Information

• Brand Name: Integra®
• Primary DI: 10381780024460
• Version / Model: NL97005S01
• Catalog Number: NL97005S01
• 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: 6
• Public Version Date: 2021-04-07
• Public Version Status: Update
• Public Device Record Key: a1f09244-4a8f-4898-a2ba-73b836b9b51f

Device Description

5 FRENCH T-TUBE The Integra Edwards-Barbaro Syringo-Peritoneal Shunt is designed to provide continuous drainage of fluid from within a spinal cord cyst to a site outside the spinal canal. The T-tube diameter is small to minimize the size of the myelotomy and the catheter is flexible to minimize the spinal cord manipulation necessary to insert the tube into a spinal cord cyst. The T-shape allows drainage above and below the myelotomy site, helps prevent kinking by providing a right-angle exit through the dura, and reduces the risk of migration out of the spinal cord. The multi-holed catheter reduces the risk of clogging at the spinal end of the system. The suture tab allows the T-tube to be anchored to the dura or paraspinous muscles without the risk of shunt occlusion associated with a circumferential ligature. If a step down connector is used, it adapts the T-tube diameter to the peritoneal reflux control catheter.

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: 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: 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
61523	Lumboperitoneal shunt	An implantable device intended to divert excessive cerebrospinal fluid (CSF) from the subarachnoid space of the lumbar spine to the peritoneal cavity where it can be absorbed into the body, as a treatment for raised CSF pressure (e.g., caused by hydrocephalus). It consists of fully-implantable interconnected components: a spinal catheter implanted into subarachnoid space of the lumbar spine; a mechanical shunt valve that may incorporate a puncturable port/reservoir for sampling/infusion; a peritoneal catheter implanted into the peritoneal cavity; some types incorporate a subcutaneous anchor for component connection/positioning. Disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780024460	GS1
Secondary	M269NL97005S011	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K854049	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			3.5cm Primary tube length, 25cm Secondary tube length (all dimensions nominal)