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Sign in to claim this brandIntegra LifeSciences Production Corporation
United States·US-MF-000009189
Last updated September 17, 2026
What Integra LifeSciences Production Corporation makes
The company manufactures reusable surgical instruments for spinal and ophthalmic procedures, including rongeurs for bone removal, general-purpose scissors, needle holders for suturing, soft-tissue manipulation forceps, retractors, curettes for bone, and intraocular scissors. Their portfolio also includes ophthalmic tweezers-like forceps for delicate tissue handling.
These devices are regulated under FDA’s Class I and Class II classifications and are listed in the FDA’s Unique Device Identifier (UDI) database. The company 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 manufacture?
Integra LifeSciences manufactures reusable surgical instruments primarily used in spinal and ophthalmic procedures. Their portfolio includes devices like spinal rongeurs for bone removal, general-purpose surgical scissors, suturing needle holders, soft-tissue manipulation forceps, retractors, bone curettes, intraocular scissors, and ophthalmic tweezers-like forceps. These instruments are designed for precision and durability in surgical settings.
Where is Integra LifeSciences based?
Integra LifeSciences is headquartered in the United States. The company’s location is relevant for regulatory compliance, as it operates under the jurisdiction of the U.S. Food and Drug Administration (FDA).
Which regulatory registries or databases list Integra LifeSciences’ devices?
Integra LifeSciences’ devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers, regulators, and other stakeholders by assigning a unique identifier to each device, facilitating tracking and compliance.
How are Integra LifeSciences’ devices classified under FDA regulations?
Integra LifeSciences’ devices fall under FDA’s Class I and Class II classifications. Class I devices are generally considered low-risk and may require general controls, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 11, Cabot Boulevard, Mansfield, MA, United States
- Website
- integralife.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- George Stradtman
- EUDAMED SRN
- US-MF-000009189
- FDA FEI Number
- 3014334038
- DUNS Number
- —
Catalogue (21188)
Page 1 of 424| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Integra® Miltex® | PM-398 | FDA UDI | Class I | Active |
| Integra® Miltex® | 20-200 | FDA UDI | Class I | Active |
| Integra® Ruggles®-Redmond™ | R0260 | FDA UDI | Class I | Active |
| Integra® Miltex® | 017-24590 | FDA UDI | Class I | Unknown |
| Integra® Ruggles®-Redmond™ | RN4892 | FDA UDI | Class II | Active |
| Integra® Jarit® | 310291 | FDA UDI | Class I | Active |
| Integra® Jarit® | 180204 | FDA UDI | Class I | Active |
| Integra® Jarit® | P6856TC | FDA UDI | Class I | Active |
| Integra® Ruggles®-Redmond™ | RN4725M | FDA UDI | Class II | Active |
| Integra® Miltex® | 012-S6007 | FDA UDI | Class I | Unknown |
| Codman® Hakim® | 823838 | FDA UDI | Class II | Active |
| Codman® Accu-Flo® | 821203 | FDA UDI | Class II | Active |
| Integra® Jarit® | 500295 | FDA UDI | Class I | Active |
| Integra® Jarit® | 285434 | FDA UDI | Class I | Active |
| Integra® Miltex® | MH8-42TC | FDA UDI | Class I | Active |
| Integra® Jarit® | 285375 | FDA UDI | Class I | Active |
| Integra® Jarit® | 450092 | FDA UDI | Class I | Active |
| Integra® Miltex® | 017-24601 | FDA UDI | Class I | Unknown |
| Integra® Miltex® | 70-192 | FDA UDI | Class I | Active |
| Integra® Ruggles®-Redmond™ | N13BL06 | FDA UDI | Class II | Active |
| Integra® Ruggles®-Redmond™ | NH13 | FDA UDI | Class II | Active |
| Integra® | 3741166 | FDA UDI | Class I | Active |
| Integra® | 3714001 | FDA UDI | Class I | Active |
| Integra® Miltex® | 012-10012 | FDA UDI | Class I | Unknown |
| Integra® Ruggles®-Redmond™ | RN28323 | FDA UDI | Class II | Unknown |
| Integra® Miltex® | DEFXC17 | FDA UDI | Class I | Active |
| Integra® Miltex® | 012-23046 | FDA UDI | Class I | Unknown |
| Integra® Miltex® | DKF31/10 | FDA UDI | Class I | Unknown |
| Integra® Jarit® | 400STY187 | FDA UDI | Class I | Active |
| Integra® Ruggles®-Redmond™ | RN85212 | FDA UDI | Class II | Active |
| Integra® Miltex® | UB24-KK | FDA UDI | Class I | Unknown |
| Integra® Miltex® | TFBL12 | FDA UDI | Class I | Unknown |
| Integra® Jarit® | P6834 | FDA UDI | Class I | Active |
| Integra® Miltex® | 6-30 | FDA UDI | Class I | Active |
| Integra® Ruggles®-Redmond™ | R1006 | FDA UDI | Class I | Active |
| Integra® Miltex® | DHP35 | FDA UDI | Class I | Unknown |
| Integra® Ruggles®-Redmond™ | R2849 | FDA UDI | Class I | Active |
| Integra® Jarit® | 835546 | FDA UDI | Class I | Active |
| Integra® Jarit® | P8632 | FDA UDI | Class I | Active |
| Integra® Jarit® | 420175 | FDA UDI | Class I | Active |
| Codman® Accu-Flo® | 821504 | FDA UDI | Class II | Active |
| Integra® Jarit® | 116115 | FDA UDI | Class I | Active |
| Integra® Miltex® | 26-1652 | FDA UDI | Class I | Active |
| Integra® Miltex® | 19-660 | FDA UDI | Class I | Active |
| Integra® Miltex® | PM-2123 | FDA UDI | Class I | Active |
| Integra® Jarit® | 121126 | FDA UDI | Class I | Active |
| Integra® Ruggles®-Redmond™ | R0711 | FDA UDI | Class II | Active |
| Integra® Miltex® | EMH257 | FDA UDI | Class I | Unknown |
| Integra® Miltex® | 27-438 | FDA UDI | Class I | Active |
| Integra® Jarit® | 840230 | FDA UDI | Class I | Active |
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