Question 1

What types of medical devices does Spectra Medical Devices, LLC primarily manufacture?

Accepted Answer

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.

Question 2

Where is Spectra Medical Devices, LLC based, and what regulatory databases list its devices?

Accepted Answer

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.

Question 3

How are Spectra Medical Devices, LLC’s devices classified under regulatory frameworks?

Accepted Answer

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.

Question 4

Are Spectra Medical Devices, LLC’s devices listed in any other regulatory registries besides eudamed and the FDA’s UDI system?

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
MSK Ultrasonic Injection Needle	S80C21-6.00BLX	FDA UDI	Class II	Active
Plastic BD Style Hub Tuohy Epidural Needle	S103418-3.50LT	FDA UDI	Class II	Active
Radiofrequency (RF) Needle	SST221505SL	FDA UDI	Class II	Active
Radiofrequency (RF) Needle	SCV220505SL	FDA UDI	Class II	Active
Radiofrequency (RF) Needle	SCV201510SL	FDA UDI	Class II	Active
Radiofrequency (RF) Needle	SST181505NC	FDA UDI	Class II	Active
Metal Standard Hub Tuohy Epidural Needle	S13514-4.008C	FDA UDI	Class II	Active
Radiofrequency (RF) Needle	SCV181010SL	FDA UDI	Class II	Active
Radiofrequency (RF) Needle	SCV161510NC	FDA UDI	Class II	Active
Radiofrequency (RF) Needle	S181510STSQ1PEL	FDA UDI	Class II	Active
Metal Standard Hub Tuohy Epidural Needle	S13514-3.508C	FDA UDI	Class II	Active
MSK Ultrasonic Injection Needle	S80C21-4.00BLX	FDA UDI	Class II	Active
Spectra Epidural Needle	S88518-3.501S	EUDAMEDFDA UDI	Class III	Active
Spectra-Glass Lor (loss Of Resistance Syringe, 5cc Metal L/S Or L/L Tip, Spectra-Glass Lor (loss Of Resistance) Syringe	K082674	FDA 510(k)	Class II	Active
Sodium Chloride Injection, 0.9%, Usp 5 Ml, 10 Ml Ampule	K103740	FDA 510(k)	Class II	Active
Spectra-Lor, 10 Ml Plastic Loss Of Resistance Syringe, L/S, Spectra-Lor, 10ml Plastic Loss Of Resistance Syringe L/L	K081524	FDA 510(k)	Class II	Active
Sterile Sodium Chloride 0.9% Flush, 5ml, 10ml, Ampule	K082689	FDA 510(k)	Class II	Active
Spectra Soft Tissue Biopsy Needles	K142791	FDA 510(k)	Class II	Active
Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford	K163292	FDA 510(k)	Class II	Active
SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle	K151069	FDA 510(k)	Class II	Active
Surgical Instruments (Spectra Radio Frequency (RF) Needle and Safety Scalpel)	SST201520NC	EUDAMEDFDA UDI	Class IIa	Active
Surgical Instruments (Spectra Radio Frequency (RF) Needle and Safety Scalpel)	SST181005SL	EUDAMEDFDA UDI	Class IIa	Active
Surgical Instruments (Spectra Radio Frequency (RF) Needle and Safety Scalpel)	SST221005SL	EUDAMEDFDA UDI	Class IIa	Active
Surgical Instruments (Spectra Radio Frequency (RF) Needle and Safety Scalpel)	SST210504NC	EUDAMEDFDA UDI	Class IIa	Active
Surgical Instruments (Spectra Radio Frequency (RF) Needle and Safety Scalpel)	SCV220504NC	EUDAMED	Class IIa	Active
Surgical Instruments (Spectra Radio Frequency (RF) Needle and Safety Scalpel)	SST181010NC	EUDAMEDFDA UDI	Class IIa	Active
Surgical Instruments (Spectra Radio Frequency (RF) Needle and Safety Scalpel)	SST220504SL	EUDAMEDFDA UDI	Class IIa	Active
Spectra Safe-Cut® Safety Scalpel	S-11SMD-SSH-BC	EUDAMED	Class IIa	Active
Surgical Instruments (Spectra Radio Frequency (RF) Needle and Safety Scalpel)	SST211010EC	EUDAMEDFDA UDI	Class IIa	Active
Spectra Guidewire Introducer Needle	S01321-2.759LF	EUDAMEDFDA UDI	Class IIa	Active
Surgical Instruments (Spectra Radio Frequency (RF) Needle and Safety Scalpel)	S-11SMD-MSS-B	EUDAMEDFDA UDI	Class IIa	Active
Surgical Instruments (Spectra Radio Frequency (RF) Needle and Safety Scalpel)	SST201010SL	EUDAMEDFDA UDI	Class IIa	Active
Surgical Instruments (Spectra Radio Frequency (RF) Needle and Safety Scalpel)	SST181510NC	EUDAMEDFDA UDI	Class IIa	Active
Surgical Instruments (Spectra Radio Frequency (RF) Needle and Safety Scalpel)	SST211005NC	EUDAMEDFDA UDI	Class IIa	Active
Surgical Instruments (Spectra Radio Frequency (RF) Needle and Safety Scalpel)	SST210505EC	EUDAMEDFDA UDI	Class IIa	Active

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