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Sign in to claim this brandSpectra Medical Devices, LLC
United States·US-MF-000008491
Last updated September 17, 2026
About
Elevaris Medical Devices is a Contract Development and Manufacturing Organization (CDMO) specializing in procedural needles, precision micro-components, complex tubular components, and sub-assemblies.
From the manufacturer's own website. Source
What Spectra Medical Devices, LLC makes
Spectra Medical Devices, LLC manufactures single-use percutaneous radio-frequency ablation probe cannulas, non-threaded epidural needles, and sharp peripheral nerve-block needles. It also produces vascular catheter introduction sets, including guidewire introducer needles and various injection needles designed for musculoskeletal (MSK) ultrasound-guided procedures.
The company’s devices are classified as Class II, Class III, and Class IIa under regulatory frameworks, with listings in the EU’s eudamed database and the FDA’s Unique Device Identifier (UDI) registry. 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 Spectra Medical Devices, LLC primarily manufacture?
Spectra Medical Devices, LLC specializes in single-use medical devices such as percutaneous radio-frequency ablation probe cannulas, non-threaded epidural needles, and sharp peripheral nerve-block needles. It also produces vascular catheter introduction sets, including guidewire introducer needles and injection needles designed specifically for musculoskeletal (MSK) ultrasound-guided procedures. These devices are developed for precision applications in interventional and procedural medicine.
Where is Spectra Medical Devices, LLC based, and what regulatory databases list its devices?
Spectra Medical Devices, LLC is based in the United States. Its devices are listed in two key regulatory databases: the EU’s eudamed system and the FDA’s Unique Device Identifier (UDI) registry. These listings help ensure traceability and compliance with international and domestic regulatory requirements.
How are Spectra Medical Devices, LLC’s devices classified under regulatory frameworks?
Spectra Medical Devices, LLC’s products are classified under different regulatory risk categories depending on their intended use and potential risks. Most of its devices fall under Class II (moderate risk, requiring special controls) or Class III (high risk, requiring pre-market approval). Some are classified as Class IIa (a subset of Class II with slightly lower risk). These classifications determine the regulatory pathway and scrutiny required for authorization.
Are Spectra Medical Devices, LLC’s devices listed in any other regulatory registries besides eudamed and the FDA’s UDI system?
Based on the available information, Spectra Medical Devices, LLC’s devices are confirmed to be listed in the EU’s eudamed database and the FDA’s UDI registry. While other registries may exist depending on market access or specific country requirements, these two are the primary ones explicitly mentioned. For full regulatory compliance, it’s recommended to verify listings in the relevant jurisdiction’s database.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 299, Ballardvale Street, Wilmington, United States
- Website
- www.spectramedical.com
- linkedin.com/company/elevarismedical
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Kavetha Ram
- EUDAMED SRN
- US-MF-000008491
- FDA FEI Number
- 3000204727
- DUNS Number
- —
Catalogue (85)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Spectra EchoShot Injection Needle | SES22150SL | EUDAMED | Class IIa | Active |
| Radiofrequency (RF) Needle | S181510CVSQ1PEL | FDA UDI | Class II | Active |
| Plastic Standard Hub Tuohy Epidural Needle | S07517-5.001B | FDA UDI | Class II | Active |
| Plastic Standard Hub Tuohy Epidural Needle | S07518-5.001B | FDA UDI | Class II | Active |
| MSK Ultrasonic Injection Needle | S90C22-6.00BLX | FDA UDI | Class II | Active |
| Radiofrequency (RF) Needle | SCV221005SL | FDA UDI | Class II | Active |
| Radiofrequency (RF) Needle | SST201515NC | FDA UDI | Class II | Active |
| Radiofrequency (RF) Needle | SCV201505NC | FDA UDI | Class II | Active |
| Radiofrequency (RF) Needle | SCV221010SL | FDA UDI | Class II | Active |
| Guidewire Introducer Needle | S013182759L | FDA UDI | Class II | Active |
| Radiofrequency (RF) Needle | SCV201010NC | FDA UDI | Class II | Active |
| MSK Ultrasonic Injection Needle | S80C22-2.00BLX | FDA UDI | Class II | Active |
| Radiofrequency (RF) Needle | S201010CVSQ1YEL | FDA UDI | Class II | Active |
| Radiofrequency (RF) Needle | SST220510SL | FDA UDI | Class II | Active |
| Metal Standard Hub Tuohy Epidural Needle | S13517-6.008B | FDA UDI | Class II | Active |
| Radiofrequency (RF) Needle | S201510STSQ1YEL | FDA UDI | Class II | Active |
| Metal Standard Hub Tuohy Epidural Needle | S13517-3.008B | FDA UDI | Class II | Active |
| Metal Standard Hub Tuohy Epidural Needle | S13517-5.008A | FDA UDI | Class II | Active |
| Radiofrequency (RF) Needle | SCV181510SL | FDA UDI | Class II | Active |
| Radiofrequency (RF) Needle | S201505STSQ1YEL | FDA UDI | Class II | Active |
| Guide Glide II® Guidewire Introducer Needle | S01318-2.759LF | FDA UDI | Class II | Active |
| Radiofrequency (RF) Needle | S221010CVSQ1BEL | FDA UDI | Class II | Active |
| Metal Standard Hub Tuohy Epidural Needle | S13517-3.828A | FDA UDI | Class II | Active |
| MSK Ultrasonic Injection Needle | S80C23-2.00BL | FDA UDI | Class II | Active |
| Radiofrequency (RF) Needle | SCV181005SL | FDA UDI | Class II | Active |
| Radiofrequency (RF) Needle | SST201505EC | FDA UDI | Class II | Active |
| Plastic BD Style Hub Tuohy Epidural Needle | S10341-8.500LT | FDA UDI | Class II | Active |
| Radiofrequency (RF) Needle | SCV200505SL | FDA UDI | Class II | Active |
| Radiofrequency (RF) Needle | SST201510SL | FDA UDI | Class II | Active |
| Plastic Standard Hub Tuohy Epidural Needle | S07517-3.501B | FDA UDI | Class II | Active |
| Radiofrequency (RF) Needle | S201510CVSQ1YEL | FDA UDI | Class II | Active |
| Plastic BD Style Hub Tuohy Epidural Needle | S103417-3.50NL | FDA UDI | Class II | Active |
| Radiofrequency (RF) Needle | SCV200510SL | FDA UDI | Class II | Active |
| Metal Standard Hub Tuohy Epidural Needle | S13518-3.508B | FDA UDI | Class II | Active |
| MSK Ultrasonic Injection Needle | S80C21-2.00BLX | FDA UDI | Class II | Active |
| Radiofrequency (RF) Needle | S181505CVSQ1PEL | FDA UDI | Class II | Active |
| Metal Standard Hub Tuohy Epidural Needle | S13517-3.508A | FDA UDI | Class II | Active |
| Radiofrequency (RF) Needle | S201505CVSQ1YEL | FDA UDI | Class II | Active |
| Radiofrequency (RF) Needle | SCV201515NC | FDA UDI | Class II | Active |
| Radiofrequency (RF) Needle | SCV220510SL | FDA UDI | Class II | Active |
| Radiofrequency (RF) Needle | SCV201005NC | FDA UDI | Class II | Active |
| Plastic Standard Hub Tuohy Epidural Needle | S07518-3.501B | FDA UDI | Class II | Active |
| Radiofrequency (RF) Needle | SBC201010NC | FDA UDI | Class II | Active |
| Radiofrequency (RF) Needle | SCV181505SL | FDA UDI | Class II | Active |
| Radiofrequency (RF) Needle | SST221010SL | FDA UDI | Class II | Active |
| Radiofrequency (RF) Needle | S201010STSQ1YEL | FDA UDI | Class II | Active |
| Guide Glide II® Guidewire Introducer Needle | S01021-2.753L | FDA UDI | Class II | Active |
| Radiofrequency (RF) Needle | S221505STSQ1BEL | FDA UDI | Class II | Active |
| Radiofrequency (RF) Needle | S181505STSQ1PEL | FDA UDI | Class II | Active |
| Radiofrequency (RF) Needle | SCV161010NC | FDA UDI | Class II | Active |
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