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Integra 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
LinkedIn
—
Facebook
—
Phone
—
PRRC Contact
George Stradtman
EUDAMED SRN
US-MF-000009189
FDA FEI Number
3014334038
DUNS Number
—

Catalogue (21188)

Page 2 of 424
DeviceModel / ReferenceRegistriesClassStatus
Integra® Miltex® PM-3825
FDA UDI
Class IActive
Integra® Miltex® 11-17
FDA UDI
Class IActive
Integra® Miltex® 6-197
FDA UDI
Class IActive
Integra® Miltex® 012-15007
FDA UDI
Class IUnknown
Integra® Miltex® 012-12501
FDA UDI
Class IUnknown
Integra® Ruggles®-Redmond™ RN9407STY
FDA UDI
Class IIUnknown
Integra® Miltex® 700-425
FDA UDI
Class IUnknown
Integra® Jarit® 250205
FDA UDI
Class IActive
Integra® Miltex® 8-96TC
FDA UDI
Class IActive
Codman® Hakim® 823086
FDA UDI
Class IIActive
Codman® Hakim® NS5111
FDA UDI
Class IIActive
Integra® Miltex® EG7-600
FDA UDI
Class IActive
Integra® Miltex® DRA4
FDA UDI
Class IActive
Integra® Miltex® MH8-8A-TC
FDA UDI
Class IActive
Integra® Jarit® P500C
FDA UDI
Class IActive
Integra® 3714117
FDA UDI
Class IActive
Integra® Jarit® 250281
FDA UDI
Class IActive
Integra® Miltex® MH8-17
FDA UDI
Class IActive
Integra® Jarit® 260105
FDA UDI
Class IActive
Integra® Ruggles®-Redmond™ RB9008
FDA UDI
Class IActive
Integra® Miltex® PM-1306M
FDA UDI
Class IActive
Integra® Jarit® 400144
FDA UDI
Class IActive
Integra® Miltex® 27-602A
FDA UDI
Class IActive
Integra® Ruggles®-Redmond™ RB7771
FDA UDI
Class IUnknown
Integra® Jarit® P9475
FDA UDI
Class IIUnknown
Integra® Jarit® 615152
FDA UDI
Class IIActive
Integra® Ruggles®-Redmond™ RB5962DT
FDA UDI
Class IIActive
Integra® Jarit® 600319L
FDA UDI
Class IIActive
Integra® 3723001
FDA UDI
Class IActive
Integra® Jarit® 225314
FDA UDI
Class IActive
Integra® Ruggles®-Redmond™ RE0802
FDA UDI
Class IActive
Integra® Ruggles®-Redmond™ RE0830
FDA UDI
Class IActive
Integra® Ruggles®-Redmond™ R1716
FDA UDI
Class IActive
Integra® Miltex® DHP558
FDA UDI
Class IActive
Integra® Ruggles®-Redmond™ RE0858
FDA UDI
Class IActive
Integra® Jarit® 355162
FDA UDI
Class IActive
Integra® Jarit® 350160
FDA UDI
Class IActive
Integra® Ruggles®-Redmond™ RD4851M
FDA UDI
Class IIActive
Integra® 3755143
FDA UDI
Class IActive
Integra® 3711022
FDA UDI
Class IActive
Integra® Miltex® PM-6540
FDA UDI
Class IActive
Integra® Miltex® 5-186
FDA UDI
Class IActive
Integra® Miltex® 5-1026
FDA UDI
Class IActive
Integra® Miltex® 17-1010
FDA UDI
Class IActive
Integra® Miltex® V919-383
FDA UDI
Class IActive
Integra® Jarit® 405152
FDA UDI
Class IActive
Integra® Jarit® P6500
FDA UDI
Class IUnknown
Integra® Ruggles®-Redmond™ RB7736
FDA UDI
Class IActive
Integra® Jarit® 625125
FDA UDI
Class IIActive
Integra® Ruggles®-Redmond™ RB5366
FDA UDI
Class IIActive

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