FDA Registration
Active
🇮🇪 Ireland
INTEGRA LIFESCIENCES (IRELAND) LIMITED
Reg #: 3006697299
·
FEI: 3006697299
·
Expires 2026
Products
11
Proprietary Names
37
Establishment Types
4
Classifications
11
Registration Details
- Registration Name
- INTEGRA LIFESCIENCES (IRELAND) LIMITED
- Registration Number
- 3006697299
- FEI Number
- 3006697299
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- IDA BUSINESS and TECHNOLOGY PARK
- City
- SRAGH TULLAMORE Offaly
- Country
- IE
Regulatory Submissions
- 510(k) Number
- K981262
Owner / Operator
- Firm Name
- Integra LifeSciences Corporation
- Operator Number
- 9004007
- Address
- 1100 Campus Rd
- City
- Princeton
- State
- NJ
- Postal Code
- 08540
- Country
- US
US Agent
- Business Name
- Integra LifeSciences Corporation
- Contact Name
- Kerri DiPietro
- Address
- 11 Cabot Blvd
- City
- Mansfield
- State
- MA
- ZIP
- 02048
- Country
- US
- [email protected]
- Phone
- 774 7196909
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Neurosurgical Ultrasonic Instruments | LBK | Class U | Unknown | No | 2005-10-03 |
| Instrument, Ultrasonic Surgical | LFL | Class U | Unknown | No | 2005-10-03 |
| Light, Surgical, Fiberoptic | FST | Class 2 | General, Plastic Surgery | No | 2007-12-04 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2003-07-15 |
| Shunt, Central Nervous System And Components | JXG | Class 2 | Neurology | No | 2019-11-01 |
| Source, Carrier, Fiberoptic Light | EQH | Class 1 | Ear, Nose, Throat | No | 2003-07-25 |
| Device, Monitoring, Intracranial Pressure | GWM | Class 2 | Neurology | No | 2012-10-25 |
| Light, Headband, Surgical | FSR | Class 2 | Ophthalmic | No | 2018-08-28 |
| Camera, Television, Surgical, With Audio | FWC | Class 1 | General, Plastic Surgery | No | 2003-07-16 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | Class 1 | Anesthesiology | No | 2020-08-20 |
| Light Source, Fiberoptic, Routine | FCW | Class 2 | Gastroenterology, Urology | No | 2016-02-03 |
Proprietary Names
CUSA EXCEL Ultrasonic Surgical Aspirator System
Integra Luxtec UltraLitePro
UltraLite Plus
Integra Flexible EEG Cable
Flexible EEG Cables
CUSA Clarity Ultrasonic Surgical Aspirator System; C7023; C7123; C7623; C7601; C7601EA
CODMAN CERTAS Plus Electronic Tool Kit
CUSA Clarity Ultrasonic Surgical Aspirator System; C7602; C7602EA
Miltex
Padgett
Integra Luxtec DLX UltraLite Pro
MicroFrance
Luxtec Fiber Optic Cables
Integra
Acclarent
Light Guide Cable Adapters
Relieva Luma Light Guide Cable 2
Integra Licox Pt02 Monitor Accessories
Micro Ventricular Bolt Pressure/Temperature Monitoring Kit
Single Parameter Monitor
SPM-1
CUSA Excel+ Ultrasonic Surgical Aspirator System; C2623; C5623; CUSAEXCEL2; C2600; C5601; C5602
CUSA Clarity 23kHz CEM Nosecone
Integra® Duo LED Surgical Headlight System
CUSA® Clarity 23 kHz Expanded CEM Nosecone
CUSA® Clarity 23 kHz Standard Laparoscopic Tip
CUSA® Clarity 23 kHz Extended Laparoscopic Tip
Integra LICOX PT02 Monitor
Integra Luxtec DLX UltraLite Pro Camera System
CUSA Clarity Custom Cart
CereLink ICP Replacement Power Supply 826822
CereLink ICP Extension Cable 826845
CereLink ICP Replacement Battery 826824
CereLink ICP Monitor 826820
Integra LED Surgical Headlight
Integra Luxtec MLX 300 Watt Xenon Light
CUSA Clarity 23 kHz Single-Sided Bone Tip
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device