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Sign in to claim this brandINTEGRA LIFESCIENCES (IRELAND) LIMITED
US
Last updated May 24, 2026
What INTEGRA LIFESCIENCES (IRELAND) LIMITED makes
The company manufactures reusable and single-use components for ultrasonic surgical systems, including reusable handpieces, handpiece tips, and torque wrenches, as well as single-use adaptors and sterilization containers. It also produces general-purpose light sources and electrical connection cables for medical devices. The portfolio includes systems like the CUSA® Clarity and CUSA® Excel, designed for soft-tissue surgical procedures.
The devices are classified under FDA’s Class I, Class II, and Unclassified (U) categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Integra Lifesciences (Ireland) Limited manufacture?
Integra Lifesciences (Ireland) Limited specializes in components for ultrasonic surgical systems, including reusable and single-use parts. Their portfolio covers reusable handpieces and handpiece tips for soft-tissue procedures, as well as single-use items like torque wrenches, adaptors, and sterilization containers. They also produce general-purpose light sources and reusable electrical connection cables for medical devices. These devices are designed to support precision surgical techniques.
Where is Integra Lifesciences (Ireland) Limited based?
The company is headquartered in the United States. While the name includes 'Ireland,' the operational base and regulatory focus align with the U.S. market, where their devices are developed and distributed.
Which regulatory registries list Integra Lifesciences’ devices?
Integra Lifesciences’ devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance tracking for medical devices authorized in the U.S., including those classified under Class I, Class II, or Unclassified (U) categories.
How are Integra Lifesciences’ devices classified by the FDA?
The company’s devices fall into three FDA classification categories: Class I (generally low-risk), Class II (moderate-risk with special controls), and Unclassified (U) for devices not yet assigned a risk level. Classification depends on factors like intended use, risk potential, and regulatory history, ensuring appropriate oversight for each product.
What is the significance of the CUSA® and Integra® systems in the company’s portfolio?
The CUSA® Clarity, CUSA® Excel, and Integra® Duo systems are core ultrasonic surgical platforms developed by the company. These systems are designed for soft-tissue procedures, combining reusable handpieces with single-use or reusable accessories to enhance precision during surgery. The naming reflects their specialized applications in neurosurgery and other delicate surgical fields.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- integralife.com
- —
- —
- [email protected]
- Phone
- +1(800)654-2873
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 989925396
Catalogue (283)
Page 1 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| CUSA® Clarity | C7420SEA | FDA UDI | U | Active |
| CUSA® Excel | C4616S | FDA UDI | U | Active |
| Cusa® Nxt | CUSANXT1 | FDA UDI | U | Unknown |
| Cusa® Nxt | NXT3219 | FDA UDI | U | Unknown |
| Integra® CUSA NXT™ | 1523243EA | FDA UDI | U | Unknown |
| Integra® | FLEX32C2 | FDA UDI | Class II | Unknown |
| Integra® | 003285NTSC | FDA UDI | Class I | Active |
| Integra® | 400355 | FDA UDI | Class II | Active |
| Integra® | 001320LX | FDA UDI | Class II | Active |
| CUSA® Selector® | 1523078 | FDA UDI | U | Unknown |
| CUSA® Excel | C4609S | FDA UDI | U | Active |
| CUSA® Excel | C2623 | FDA UDI | U | Active |
| CUSA® Clarity | C7550 | FDA UDI | U | Active |
| CUSA® Excel | C2600 | FDA UDI | U | Active |
| CUSA® Selector® | 1523030 | FDA UDI | U | Unknown |
| Integra® | FLEX10C1 | FDA UDI | Class II | Unknown |
| CUSA® Excel | C5601 | FDA UDI | U | Active |
| CUSA® Excel | C4611S | FDA UDI | U | Active |
| Integra® Duo | 90670 | FDA UDI | Class II | Active |
| CUSA® Excel | C2602 | FDA UDI | U | Active |
| CUSA® Clarity | C7005 | FDA UDI | U | Active |
| CUSA® Excel | C3600 | FDA UDI | U | Active |
| CUSA® Selector® | 1523035 | FDA UDI | U | Unknown |
| CUSA® Selector® | 1523013 | FDA UDI | U | Unknown |
| CUSA® Selector® | 1523023 | FDA UDI | U | Active |
| Integra® Duo | 90620US | FDA UDI | Class II | Active |
| CUSA® Clarity | C7420S | FDA UDI | U | Active |
| Integra® | FLEX02C1 | FDA UDI | Class II | Unknown |
| CUSA® Selector® | 1523043 | FDA UDI | U | Unknown |
| Integra® | ICP-46 | FDA UDI | Class II | Active |
| Integra® | 001380LX | FDA UDI | Class II | Active |
| Integra® | FLEX20C2 | FDA UDI | Class II | Unknown |
| CUSA® Selector® | 1529066 | FDA UDI | U | Unknown |
| Camino® | AP06 | FDA UDI | Class II | Unknown |
| Cusa® Nxt | NXT80003 | FDA UDI | U | Active |
| CUSA Clarity® | C7007P | FDA UDI | U | Active |
| CUSA® Excel MacroTip™ | C4605S | FDA UDI | U | Active |
| CUSA® Selector® | 1523047 | FDA UDI | U | Unknown |
| Integra® | FLEX04C1 | FDA UDI | Class II | Unknown |
| CUSA® Excel | C6623 | FDA UDI | U | Active |
| Camino® | CAMCABL | FDA UDI | Class II | Unknown |
| Integra® | FLEX64C4 | FDA UDI | Class II | Unknown |
| Integra® | ICP-16 | FDA UDI | Class II | Active |
| CUSA® Selector® | 1523072M2 | FDA UDI | U | Unknown |
| CUSA® Selector® | 1523049 | FDA UDI | U | Unknown |
| CUSA® Selector® | 1523000M2 | FDA UDI | U | Unknown |
| CUSA® Excel | CV260438000 | FDA UDI | U | Active |
| CUSA® Excel | C4617S | FDA UDI | U | Active |
| CUSA® Selector® | 1523032 | FDA UDI | U | Unknown |
| CUSA® Selector® | 1523231 | FDA UDI | U | Unknown |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Integra Lifesciences (ireland) Limited SRAGH TULLAMORE Offaly · IE FEI 3006697299