Integra®

Basic Information

• Brand Name: Integra®
• Primary DI: 10381780037217
• Version / Model: OCS2PND
• 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: 2016-08-08
• Public Version: 5
• Public Version Date: 2023-02-09
• Public Version Status: Update
• Public Device Record Key: 76dc736d-7b13-4f13-85f4-4c1ee7191abc
• Distribution End Date: 2021-04-09

Device Description

The OCS2PND is a bipolar stimulating probe for cortical stimulation with malleable tips for precise localization. The probe has 2 mm diameter polished balls, spaced 5 mm apart, at the tip of the stimulator probe. It has a 310 cm cord with two electrically shrouded banana plugs for attachment to the OCS2 Ojemann Cortical Stimulator. It is reusable, is supplied non-sterile and must be sterilized before use.

Device Characteristics

• Single Use: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GYC	ELECTRODE, CORTICAL	Neurology	882.1310	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61100	Neurosurgical probe	A non-sterile, slender, rod-like, hand-held manual surgical instrument, typically made of metal, with an angled tip and a handle, designed for exploring/dissecting intracranial structures during a surgical procedure (e.g., tumour removal, third ventriculostomy, cyst fenestration). This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M272OCS2PND1	HIBCC
Primary	10381780037217	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K924226	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dry place