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Sign in to claim this brandCarnegie Surgical LLC
US
Last updated May 24, 2026
What Carnegie Surgical LLC makes
Carnegie Surgical LLC manufactures reusable and single-use laryngoscope blades and handles, including rigid intubation laryngoscopes, as well as reusable hand-held surgical retractors and ear speculums. Their product line also includes reusable, non-illuminating surgical suction cannulas for emergency and procedural use.
All devices produced by Carnegie Surgical LLC fall under Class I regulatory classification in the US and are listed in the FDA’s Udip database. The company operates from 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 Carnegie Surgical LLC manufacture?
Carnegie Surgical LLC specializes in surgical instruments primarily used in airway management and otolaryngology. Their product line includes reusable and single-use laryngoscope blades and handles, such as rigid intubation laryngoscopes, reusable hand-held surgical retractors, reusable ear speculums, and reusable non-illuminating surgical suction cannulas. These devices are designed for emergency and procedural use in clinical settings.
Where is Carnegie Surgical LLC based?
Carnegie Surgical LLC is headquartered in the United States. The company’s location is relevant for understanding its regulatory jurisdiction and compliance framework, particularly for devices marketed within the US.
Which regulatory registries list Carnegie Surgical LLC’s devices?
Carnegie Surgical LLC’s devices are listed in the FDA’s Udip (Unique Device Identifier Program) database. This registry is used to track and identify medical devices in the US, ensuring traceability and compliance with regulatory requirements.
How are Carnegie Surgical LLC’s devices classified under US regulations?
All devices manufactured by Carnegie Surgical LLC fall under Class I regulatory classification in the US. This classification applies to low-risk devices, such as reusable surgical instruments and single-use airway tools, where general controls are sufficient to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- carnegiesurgical.com
- —
- —
- [email protected]
- Phone
- (609) 249-2696
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 017636482
Catalogue (270)
Page 5 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Carnegie Surgical LLC | 554-23212 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 404-643 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 404-734 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 404-740 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 404-7407 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 404-7607 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 404-590 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 504-792 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 404-7627 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 550-13251 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 404-591 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 404-711 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 404-630 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 572-1081 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 404-8051 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 572-1130 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 404-8023 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 504-681 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 404-7648 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 404-631 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 404-5120 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 509-43016 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 550-1335 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 506-3703 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 404-512 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 404-8050 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 549-05221 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 404-6439 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 404-6648 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 404-6429 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 572-1066 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 504-683 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 546-38015 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 544-02103 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 544-02130 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 404-6281 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 404-66385 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 506-3804 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 544-02129 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 404-8013 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 588-22003 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 404-6035 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 404-8001 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 546-47921 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 550-1337 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 554-311025F | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 504-691 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 504-781 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 404-8202 | FDA UDI | Class I | Active |
| Carnegie Surgical LLC | 511-048 | FDA UDI | Class I | Active |
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