Integra®

Basic Information

• Brand Name: Integra®
• Primary DI: 10381780034391
• Version / Model: 990001
• 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: 2016-09-01
• Public Version: 5
• Public Version Date: 2024-02-05
• Public Version Status: Update
• Public Device Record Key: b61959b0-8769-47e3-9ece-a1012ed85ae5
• Distribution End Date: 2021-12-31

Device Description

The Tunneler is a single-use instrument consisting of a stainless steel cannula with removable handle, plastic line with bullet-shaped end and barbed end, and sheath. The tunneler (45 cm) is used to make a subcutaneous tunnel between two incisions for procedures such as the subcutaneous insertion of the peritoneal drainage catheter of a hydrocephalus shunt. The barbed end is intended to be connected to a 0.8 to 1.4 mm internal diameter 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: 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
GYK	Instrument, shunt system implantation	Neurology	882.4545	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46801	Subcutaneous tunneller, single-use	A hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues and is not a dedicated pacing or defibrillation lead tunneller. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30381780034395	GS1	BOX	5	Not in Commercial Distribution	2021-12-31
Primary	10381780034391	GS1
Secondary	M2729900011	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K932273	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			45cm Length x 3.5mm I.D.