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
Instrument, Shunt System Implantation GYK
Shunt, Central Nervous System And Components JXG
Neurosurgical Ultrasonic Instruments LBK
Instrument, Ultrasonic Surgical LFL
Tape, Measuring, Rulers And Calipers FTY
Retractor GAD
Bone Grafting Material, Synthetic LYC
Cuff, Nerve JXI
Dura Substitute GXQ
Cannula, Ventricular HCD
Agent, Absorbable Hemostatic, Collagen Based LMF
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass DWF
Securement Wound Dressing For Reduction Of Infection SEL
Material, Dressing, Surgical, Polylactic Acid LPG

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