FDA.reportPublic FDA data

Integra®

Primary DI
10381780037217
Brand
Integra®
Company
INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
Model
OCS2PND
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.
Published
2016-08-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GYCELECTRODE, CORTICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GYCElectrode, CorticalNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K924226000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K924226000OJEMANN CORTICAL STIMULATORRadionics, Inc.1993-04-21GYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780037217PrimaryGS10
M272OCS2PND1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178003721710381780037217

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical probeA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
531408342
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780250371Licox ®VK522016-08-04
10381780023715Integra®910110A910110A2015-10-01
10381780034117External Drainage Set9101092016-06-24
10381780034131Drainage Accessory Kit9101229101222015-10-01
10381780034186Integral Drainage Set9104109104102015-10-01
10381780035541External Drainage Set910116A910116A2015-10-01
10381780035558External Drainage Set910116D910116D2015-10-01
10381780035602Integral Drainage Set910410B910410B2015-10-01
10381780034124Lumbar Catheter Accessory Kit9101219101212015-10-01
10381780034193Integral Drainage Set9104129104122015-10-01
10381780034209Integral Drainage Set9104209104202015-10-01
10381780035527External Drainage Set910112A910112A2015-10-01
10381780035565External Drainage Set910120A910120A2015-10-01
10381780035589External Drainage Set910123A910123A2015-10-01
10381780457305Contour-Flex Valve and Shunt System11811118112018-01-12
10381780457312Contour-Flex Valve and Shunt System11812118122018-01-12
10381780457329Contour-Flex Valve and Shunt System11813118132018-01-12
10381780457459Contour-Flex Valve and Shunt System14085140852018-01-12
10381780457466Contour-Flex Valve and Shunt System14086140862018-01-12
10381780457473Contour-Flex Valve and Shunt System14087140872018-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00840067103029ZenithCADWELL INDUSTRIES, INC.GYC2025-12-31
00848530106195Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.GYC2025-07-02
10848530106192Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.GYC2025-07-02
00850011306338ATLAS Stim Headbox - TouchproofNEURALYNX, INC.GYC2025-06-11
00850011306345ATLAS Stim Headbox - High DensityNEURALYNX, INC.GYC2025-06-11
00850011306703ATLAS Stim Headbox SoftwareNEURALYNX, INC.GYC2025-06-11
00850011306710Fiber Optic Connector 2mNEURALYNX, INC.GYC2025-06-11
00850011306727Fiber Optic Connector 7mNEURALYNX, INC.GYC2025-06-11
00850011306901ATLAS Headbox Interface Cable - TouchproofNEURALYNX, INC.GYC2025-06-11
00850011306918ATLAS Headbox Interface Cable - NKNEURALYNX, INC.GYC2025-06-11
00850011306925ATLAS Headbox Interface Cable - High DensityNEURALYNX, INC.GYC2025-06-11
00867718000285ATLAS Stim Headbox - NKNEURALYNX, INC.GYC2025-06-11
00848530106249Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.GYC2025-06-03
10848530106246Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.GYC2025-06-03
00848530093693Suction KitSUNSET HEALTHCARE SOLUTIONS, INC.GYC2025-05-19
00650551005445CORTAC®PMT CORPORATIONGYC2025-04-25
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00650551002840CORTAC®PMT CORPORATIONGYC2025-03-17
00650551002918CORTAC®PMT CORPORATIONGYC2025-03-17
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