Integra®

GUDID M2729101261

The Intracranial Pressure Monitoring Cup Catheter (85 cm) acts as a hydrostatic coupler that can be attached to an external physiologic pressure transducer/recorder system to display and/or record intracranial pressure and waveforms in the conventional manner.

INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter, short-term Intracerebral sensor catheter, short-term Intracerebral sensor catheter, short-term Intracerebral sensor catheter, short-term Intracerebral sensor catheter, short-term Intracerebral sensor catheter, short-term

• Primary Device ID: M2729101261
• NIH Device Record Key: 736dec16-3c4d-4067-ab49-7014de005a47
• Commercial Distribution Discontinuation: 2021-06-04
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Integra®
• Version Model Number: 910126
• Company DUNS: 531408342
• Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780034155 [Primary]
HIBCC	M2729101261 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K854657

FDA Product Code

• GWM: DEVICE, MONITORING, INTRACRANIAL PRESSURE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-06-04
• Device Publish Date: 2016-08-08

On-Brand Devices [Integra®]

• M272EDSEP1: The Integra Sphenoidal Electrode is designed for investigative intraoperative monitoring of cort
• M27240M081: The Integra Sphenoidal Electrode is designed for investigative intraoperative monitoring of cort
• M272EDSCF1: The electrode connecting cable EDSCF is a reusable device used to connect the Integra® Sphenoid
• M272ECCFS641: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M272ECCFS481: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M272ECCFS321: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M272ECCFS241: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M272ECCFS021: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M27240M721: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M27240M641: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M27240M581: The T-shaped female electrode connecting cable is a reusable device used to connect the Integra�
• M27240M571: The T-shaped female electrode connecting cable is a reusable device used to connect the Integra�
• M27240M561: The T-shaped female electrode connecting cable is a reusable device used to connect the Integra�
• M27240M551: The T-shaped female electrode connecting cable is a reusable device used to connect the Integra�
• M27240M441: The T-shaped female electrode connecting cable is a reusable device used to connect the Integra�
• M27240M401: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M27240M391: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M27240M381: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M27240M371: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M27240M361: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M27240M351: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M27240M341: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M27240M331: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M27240M321: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M2729101261: The Intracranial Pressure Monitoring Cup Catheter (85 cm) acts as a hydrostatic coupler that can
• M2729101251: The Intracranial Pressure Monitoring Cup Catheter (100 cm) acts as a hydrostatic coupler that ca
• 30381780035507: The External Drainage Set (EDS) consists of: an extension tubing line with a T fitting and a fou
• M272OCS2PND1: The OCS2PND is a bipolar stimulating probe for cortical stimulation with malleable tips for prec
• M2729MD2701: The Integra Peritoneal Introducer is a reusable, stainless steel obturator with a suture hole in
• M2729012241: The Integra 61 cm Peritoneal Introducer is a reusable, stainless steel obturator with a suture h
• M2729012181: The Integra 46 cm Peritoneal Introducer is a reusable, stainless steel obturator with a suture h
• M2729012121: The Integra 31 cm Peritoneal Introducer is a reusable, stainless steel obturator with a suture h
• 30381780034425: The 31 cm Peritoneal Introducer Sheath is designed to be used with a Peritoneal Introducer of ap
• 30381780034418: The Tunneler is a single-use instrument consisting of a stainless steel cannula with removable h
• 30381780034395: The Tunneler is a single-use instrument consisting of a stainless steel cannula with removable h
• 30381780033206: The 61 cm Peritoneal Introducer Sheath is designed to be used with a Peritoneal Introducer of ap
• 30381780033176: The 46 cm Peritoneal Introducer Sheath is designed to be used with a Peritoneal Introducer of ap
• 30381780023719: The External Drainage Set (EDS) consists of: an extension tubing line with a T fitting and a fou
• M272PS2P1: The non sterile Peña Muscle Stimulator Bipolar Probe (PS2P) is a 17 cm long reusable probe for
• M272ECCFS201: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M272ECCFS161: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M272ECCFS121: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M272ECCFS101: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M272ECCFS081: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M272ECCFS061: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M272ECCFS041: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M272ECCF81: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M272ECCF64161: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M272ECCF641: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica
• M272ECCF61: The female electrode connecting cable is a reusable device used to connect the Integra® Cortica