FDA Registration
Active
🇺🇸 United States
INTEGRA NEUROSCIENCES
Reg #: 2648988
·
FEI: 3000204775
·
Expires 2026
Products
14
Proprietary Names
85
Establishment Types
1
Classifications
14
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Registration Details
- Registration Name
- INTEGRA NEUROSCIENCES
- Registration Number
- 2648988
- FEI Number
- 3000204775
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ROAD 402 NORTH, KM 1.2
- City
- ANASCO
- State
- PR
- ZIP
- 00610
- Country
- US
Regulatory Submissions
- 510(k) Number
- K895868
- PMA Number
- P850010
Owner / Operator
- Firm Name
- Integra LifeSciences Corporation
- Operator Number
- 9004007
- Address
- 1100 Campus Rd
- City
- Princeton
- State
- NJ
- Postal Code
- 08540
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Shunt System Implantation | GYK | Class 1 | Neurology | No | 2007-12-12 |
| Shunt, Central Nervous System And Components | JXG | Class 2 | Neurology | No | 2016-09-27 |
| Neurosurgical Ultrasonic Instruments | LBK | Class U | Unknown | No | 2005-10-03 |
| Instrument, Ultrasonic Surgical | LFL | Class U | Unknown | No | 2005-10-03 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Bone Grafting Material, Synthetic | LYC | Class 2 | Dental | No | 2007-11-30 |
| Cuff, Nerve | JXI | Class 2 | Neurology | No | 2007-11-30 |
| Dura Substitute | GXQ | Class 2 | Neurology | No | 2007-11-30 |
| Cannula, Ventricular | HCD | Class 1 | Neurology | No | 2007-12-12 |
| Agent, Absorbable Hemostatic, Collagen Based | LMF | Class 3 | General, Plastic Surgery | No | 2007-11-30 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2007-12-12 |
| Securement Wound Dressing For Reduction Of Infection | SEL | Class U | Unknown | No | 2006-06-26 |
| Material, Dressing, Surgical, Polylactic Acid | LPG | Class 3 | Unknown | No | 2007-11-30 |
Proprietary Names
Disposable Shunt Passer
Horizontal-Vertical Lumbar Valve System
Spetzler Lumbar Peritoneal Shunt Systems
Hermetic Lumbar Catheters
Hermetic Plus External CSF Drainage
MoniTorr ICP External CSF Drainage
CUSA EXCEL Ultrasonic Surgical Aspirator System
TRAUMA CATHETER, VENTRICULAR CATHETER SET
Jarit
Integra
Ruggles-Redmond
Miltex
Padgett
MicroFrance
Wound Measuring Kit
MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System
VENTRICULAR DRAINAGE SYSTEM
Hermetic
Galea Elevator
Arkis Galea Elevator
MoniTorr CSF External Drainage Syst
CUSA Clarity Ultrasonic Surgical Aspirator System; C7023; C7123; C7623; C7601; C7601EA
OraMem Absorbable Collagen Membrane
BioMend Absorbable Collagen Membrane
HeliMend Absorbable Collagen Membrane
Pudenz Flushing Valve
NeuraWrap Nerve Protector
CUSA® Clarity 23 kHz Expanded CEM Nosecone
Maurice Worldwide Shunt System
Essential Shunt Kits
CUSA® Clarity 23 kHz Standard Laparoscopic Tip
CUSA® Clarity 23 kHz Extended Laparoscopic Tip
Suturable DuraGen Dural Regenration Matrix
Accudrain External CSF Drainage Sys
LPV II Standard and Mini Valves
External CSF Drainage Systems
Fischer
Fischer Cannula
CODMAN Elsberg Ventricular Cannula
External Drainage Set
CUSA Clarity Ultrasonic Surgical Aspirator System; C7602; C7602EA
CUSA Excel+ Ultrasonic Surgical Aspirator System; C2623; C5623; CUSAEXCEL2; C2600; C5601; C5602
Helistat Absorbable Collagen Hemostatic Sponge
Helitene Absorbable Collagen Hemostatic Agent
OraFOAM Absorbable Collagen Hemostatic Sponge
Novus Valve System
Alleghany CSF External Drainage Sys
Pudenz Catheters
Integra Reservoirs
Braden Reservoir
Pudenz Peritoneal Catheter
Mishler Valve Systems
Hermetic External CSF Drainage Syst
Pudenz Valves
On-Off Flushing Valves
Multi-Purpose Valves
Pudenz Cardiac Catheters
Codman External Drainage System II
Spetzler Lumbar-Peritoneal System
Sundt Shunt
External Corotid Shunts
OraMem Sustained Absorbable Collagen Membrane
Biomend Extend Absorbable Collagen Membrane
HeliMend Advanced Absorbable Collagen Membrane
CUSA Clarity 23 kHz Single-Sided Bone Tip
Edwards Barbaro Syringo Shunt Syste
DuraGen Dural Graft Matrix
Pudenz In-line Valve Systems
LimiTorr Volume Limiting Drainage
Biopatch
CUSA Clarity 23kHz CEM Nosecone
Endoscopic Ventricular Catheter
HeliTape Absorbable Collagen Wound Dressing
CollaPlug Absorbable Collagen Wound Dressing
HeliCote Absorbable Collagen Wound Dressing
HeliPlug Absorbable Collagen Wound Dressing
OraTape Absorbable Collagen Wound Dressing
OraPlug Absorbable Collagen Wound Dressing
CollaCote Absorbable Collagen Wound Dressing
CollaTape Absorbable Collagen Wound Dressing
MISHLER 2 CHAMB FLUSHING VALVE,ANTI-SYP
NeuraGen Nerve Guide
STERILE STD LPV WITH RIGHT ANGLE
DuraGen XS Dural Regeneration Matrix
DuraGen Plus Dural Regeneration Matrix
Establishment Types
Manufacture Medical Device