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Sign in to claim this brandWhat ORTHOCELL LIMITED makes
OrthoCell Limited manufactures collagen-based dental regeneration membranes and nerve guides derived from animal sources. Their products include resorbable membranes like Striate+™ and Remplir™, designed for guided bone or tissue regeneration in dental procedures, as well as tubular nerve guides like perFORM™ for peripheral nerve repair.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable regulatory standards for medical devices in that jurisdiction.
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 OrthoCell Limited manufacture?
OrthoCell Limited specializes in collagen-based medical devices for dental and nerve applications. Their primary products include resorbable collagen membranes, such as Striate+™ and Remplir™, which are used in guided bone or tissue regeneration during dental procedures. Additionally, they produce tubular nerve guides like perFORM™, designed for peripheral nerve repair. These devices leverage animal-derived collagen to support tissue regeneration.
Where is OrthoCell Limited based, and what regulatory jurisdiction does it operate under?
OrthoCell Limited is based in the United States. As a US-based manufacturer, its devices must comply with FDA regulations, including classification and listing requirements. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, which is a public registry for tracking medical devices authorized for use in the US.
How are OrthoCell Limited’s devices classified under FDA regulations?
OrthoCell Limited’s devices are classified as Class II under FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. The classification ensures that these products undergo specific review processes, including performance standards or post-market surveillance, to maintain regulatory compliance.
Which regulatory registries or databases list OrthoCell Limited’s devices?
OrthoCell Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a standardized approach to identifying medical devices throughout their distribution and use. Listing in this database helps ensure traceability and transparency for authorized devices in the US market.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 754598449
Catalogue (11)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Striate+™ | OCG-304 | FDA UDI | Class II | Active |
| perFORM™ | perf2030 | FDA UDI | Class II | Active |
| Striate+™ | OCG-203 | FDA UDI | Class II | Active |
| Remplir™ | ON-304 | FDA UDI | Class II | Active |
| Striate+™ | OCG-405 | FDA UDI | Class II | Active |
| perFORM™ | perf3040 | FDA UDI | Class II | Active |
| Remplir™ | ON-203 | FDA UDI | Class II | Active |
| Remplir™ | ON-152 | FDA UDI | Class II | Active |
| Striate+™ | OCG-152 | FDA UDI | Class II | Active |
| Remplir™ | ON-405 | FDA UDI | Class II | Active |
| perFORM™ | perf1520 | FDA UDI | Class II | Active |
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