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SonoPlex STIM and SonoPlex II Needles equipped with Cornerstone reflectors are used to puncture the tissue in order to gain entry and inject local anesthetics to induce regional anesthesia. An electrical stimulus may be applied to the needle via a cable and connector to assist the physician pinpoint the area of application.

The subject device, the SonoPlex STIM and SonoPlex II nerve block needle is a single-use anesthesia conducting needle intended to gain entry or puncture the tissue and inject anesthetics to induce regional anesthesia. The SonoPlex STIM and SonoPlex II needle is intended for use under ultrasound guidance. Visibility under ultrasound is enhanced by CornerStone reflectors as cleared by FDA in several Premarket Notification Submissions. The SonoPlex STIM and SonoPlex II needle is equipped with an connecting cable, injection tube and NanoLine® coating (Parylene, no nanomaterials incorporated). The distal connection of the tube is either equipped with a LUER Connector according to ISO 80369-7 or a NRFit-Connector according to ISO 80369-6. The device in focus is a single use device and has an intended time of use up to 24 hours acc. EO-residuals acc. DIN EN ISO 10993-7. The standard time of use is less than 60 minutes. The SonoPlex STIM and SonoPlex II cannulas are not for intrathecal use. The SonoPlex STIM and SonoPlex II cannulas are produced at PAJUNK® GmbH Medizintechnologie in Geisingen, Germany.

The SPROTTE® STANDARD (LUER/ NRFit®) lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection/ withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/ discography.

The subject device, the SPROTTE® STANDARD (LUER/ NRFit®) anaesthesia conduction needle is a single-use anaesthesia conducting intended for administer anesthetic agent to the spinal space. The SPROTTE® cannulas are equipped with a stylet as well as optional with an Introducer. It is available with a LUER respectively with a NRFit® hub. The LUER is either a standard hub, a magnifying hub or a 2.G hub. The cannula tube is straight. The distal connection of the hub is either equipped with a LUER Connector according to ISO 80369-7 or a NRFit-Connector according to ISO 80369-6.

The SonoTAP and SonoTAP II anaesthesia conduction needles enhanced for ultrasound visibility are intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia.

The subject device, the SonoTAP II needles are single-use anaesthesia conducting needles intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia. The SonoTAP and SonoTAP II needles are intended for use under ultrasound guidance. Visibility under ultrasound is enhanced by CornerStone reflectors as cleared by FDA in several Premarket Notification Submissions. The SonoTAP and SonoTAP II needles is equipped with an injection tube. The distal connection of the tube is either equipped with a LUER Connector according to ISO 80369-7 or a NRFit-Connector according to ISO 80369-6. The device in focus is a single use device and has an intended time of use up to 24 hours acc. EO-residuals acc. DIN EN ISO 10993-7. The standard time of use is less than 60 minutes. The SonoTAP and SonoTAP II cannulas are not for intrathecal use.

The SPROTTE® STANDARD (LUER/ NRFit®) needles are anesthesia conduction needles which are used to administer anesthetic agent to the subarachnoid space.

The subject device, the SPROTTE® STANDARD (LUER/ NRFit®) anaesthesia conduction needle is a single-use anaesthesia conducting intended for administer anesthetic agent to the subarachnoid space. The SPROTTE® cannulas are equipped with a stylet as well as optional with an Introducer. It is available with a LUER respectively with a NRFit® hub. The LUER is either a standard hub, a magnifying hub or a 2.G hub. The cannula tube is straight. The distal connection of the hub is either equipped with a LUER Connector according to ISO 80369-7 or a NRFit-Connector according to ISO 80369-6.

SonoBlock and SonoBlock II Needles equipped with Cornerstone reflectors are used to puncture the tissue in order to gam entry and inject local anaesthetics to induce regional anaesthesia. Warning: SonoBlock and SonoBlock II Needles are not intended for RF ablation or any other type of ablation procedure.

The subject device, the SonoBlock II nerve block needle is a single-use anaesthesia conducting nerve block needle intended for performing peripheral nerve blocks. The SonoBlock and SonoBlock II nerve block needle is intended for use under ultrasound guidance. Visibility under ultrasound is enhanced by CornerStone reflectors as cleared by FDA in several Premarket Notification Submissions.

As a powered muscle stimulator (NMES) the Stim2Go is indicated for the following conditions: - Relaxation of muscle spasm - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion As a transcutaneous electrical nerve stimulator (TENS) for pain relief the Stim2Go is indicated for the following conditions: - Symptomatic relief and management of chronic (long-term), intractable pain - Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain As a biofeedback device the Stim2Go is indicated for the following condition: - Muscle re-education purposes As a functional neuromuscular stimulator, the Stim2Go is indicated for the following conditions: - Helps to relearn voluntary motor functions of the extremities The movement-based biofeedback can only be used for patients with an active range of motion (ROM) which is defined as the ability of volitional movement resulting in a change of the concerned limb inclination angle of at least 10 degrees.

The Stim2Go is a portable, hand-held / body-worn electrical stimulation device mainly for the treatment of neurological patients with motor and/or sensory impairments. Stim2Go offers transcutaneous electrical stimulation of peripheral nerves (motor and/or sensory). Typically, Stim2Go is used to elicit muscle contractions (known as Neuro Muscular Electrical Stimulation (NMES)), to treat pain (known as Transcutaneous Electrical Nerve Stimulation (TENS)) or to be applied as Functional Electrical Stimulation (FES). Stim2Go uses a built-in sensor to analyze the patient's movement data in real time. Based on the analysis result, pre-configured stimulation patterns can be triggered to achieve a specific, predetermined effect based on the patient's movements. Stim2Go is intended for use in a clinical setting or when used by end users in home care, then necessarily with assistance. It is intended for use as an on-demand service - not permanently. Stim2Go is controlled wirelessly by a smart device – the App is freely available in the Appstore. The App allows users to execute a variety of therapy programs and even to control parameters on a very detailed level. Stim2Go is tested and certified according to the international standards for medical electrical devices and systems.

The Disposable Pre-calibrated Biopsy Needle for brain biopsy is a single-use device intended for use in stereotactic and other guided biopsy of brain tissue, for example brain tumors. The Disposable Pre-calibrated Biopsy Needle is provided in a set.

The Disposable Pre-calibrated Biopsy Needle is a dual cannula device made from stainless steel. The cannula requires vacuum suction provided by a syringe to draw the tissue into the needle. The inner cannula is then rotated against the outer cannula to cut the tissue. Biopsy needles are used to perform a biopsy of brain tissue. In the area of the blunt tip, they have a lateral biopsy window (Sedan Type) on which the biopsy is obtained. Through navigation systems or a stereotactic frame, the biopsy window is brought to the place of interest. Brainlab cranial navigation allows the tracking and calculation of the position of instruments with attached reflective tracking marker. It is one possible method of navigation. There are different versions of the Disposable Brain Biopsy Needle 2.0 for following use-cases: Guide: In the use case "Guide" the Biopsy Needle shall be used with Brainlab optical cranial navigation system with Brainlab VarioGuide. Brainlab Frameless Biopsy System or Brainlab VarioGuide Robotics. Therefore, a tracking marker array attached to Biopsy Needle shall allow the depth tracking of the instrument and calculation of the cutting window position. Frame: In the use case "Frame" the Biopsy Needle shall be used with the Elekta Leksell stereotactic frame. A defined length and exact stop shall allow the precise inserting of the Biopsy Needle in the stereotactic frame.

The Disposable Brain Biopsy Needle 2.0 for brain biopsy is a single-use device intended for use in stereotactic and other guided biopsy of brain tissue, for example brain tumors. The Disposable Brain Biopsy Needle 2.0 is provided in a set.

Biopsy needles are used to perform a biopsy of brain tissue. In the area of the blunt tip, they have a lateral biopsy window (Sedan Type) on which the biopsy is obtained. Through navigation systems or a stereotactic frame, the biopsy window is brought to the place of interest. Brainlab cranial navigation allows the tracking and calculation of the position of instruments with attached reflective tracking marker. It is one possible method of navigation. There are different versions of the Biopsy Needle for following use-cases: Guide: In the use case "Guide" the Biopsy Needle shall be used with Brainlab optical cranial navigation system with Brainlab VarioGuide, Brainlab Frameless Biopsy System or Brainlab VarioGuide Robotics. Therefore, a tracking marker array attached to Biopsy Needle shall allow the depth tracking of the instrument and calculation of the cutting window position. Frame: In the use case "Frame" the Biopsy Needle shall be used with the Elekta Leksell stereotactic frame. A defined length and exact stop shall allow the precise inserting of the Biopsy Needle in the stereotactic frame.

The E-Cath STIM acc. Tsui System is indicated for delivery of medication for regional anesthesia and pain management. Route of administration may be intraoperative, percutaneous, or perineural. To assist the physician pinpoint the area of application an electrical stimulus can be applied to the conduction needle removal, to assist the physician pinpoint conduction catheter placement, an electrical stimulus can be applied to the conduction catheter tip via the catheter adapter. The E-Cath STIM acc. Tsui System is contraindicated for the epidural space.

The Over-the-needle (OTN) Catheter Systems are available in different designs with cannula and catheter in different sizes. The system includes: SonoPlex cannula, permanent cannula, E-Cath catheter, locking cap.