NCS LAB SRL

Address:Via Pola Esterna 4/12,Carpi Modena,IT

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- Catalog Number : A000115

Device Description : The implantable device Elite SPK is intended for the attachment of soft tissue t The implantable device Elite SPK is intended for the attachment of soft tissue to bone during arthroscopic or open treatment of rotator cuff tears. The implant device is packaged with previously cleared sutures, in their final sterilized form

Device Class : 2

Duns Number: 429763668

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

Device Description : Complete set of surgical instrument to be used with Superelastic Transosseous Ne Complete set of surgical instrument to be used with Superelastic Transosseous Needle (STN).

Device Class : 1

Duns Number: 429763668

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Device Description : The configuration is composed of an electrostimulator and other components, usef The configuration is composed of an electrostimulator and other components, useful for recharging, wearing, stimulating and/or controlling it.The SPM01M1 configuration supports Bluetooth Low Energy communication. In this case it can connect directly to a smartphone/tablet on which a dedicated app is installed. The dedicated control software is supplied via an usb receiver and must be used by a properly trained healthcare professional.

Device Class : 1

Duns Number: 429763668

Premarket Exempt : No

Product Code : IPF, KQX

Prescription Use : Yes

Device Count : 1

Device Description : The configuration is composed of an electrostimulator and other components, usef The configuration is composed of an electrostimulator and other components, useful for recharging, wearing, stimulating and/or controlling it. The SPM01M2 configuration supports IEEE 802.15.4 radio interface. In this case it provides for the exchange of data between the stimulator and a receiver connected to the PC, which then collects the data sent by the device and synchronizes the transmission. The dedicated control software is supplied via an usb receiver.

Device Class : 1

Duns Number: 429763668

Premarket Exempt : No

Product Code : IPF, KQX

Prescription Use : Yes

Device Count : 1

- Catalog Number : SPM01A1

Device Description : Optionally, the electrostimulator (SPM01M1) can require the combined use with th Optionally, the electrostimulator (SPM01M1) can require the combined use with the MySPM mobile application, as accessory of the Subject device. It allows to monitor the user and guide rehabilitation and training through specific protocols.

Device Class : 1

Duns Number: 429763668

Premarket Exempt : No

Product Code : IPF, KQX

Prescription Use : Yes

Device Count : 1

- Catalog Number : SPM01A2

Device Description : Optionally, the electrostimulator (SPM01M1) can require the combined use with th Optionally, the electrostimulator (SPM01M1) can require the combined use with the MySPM@Home mobile application, as accessory of the Subject device. It allows to monitor the user and guide rehabilitation and training through specific protocols.

Device Class : 1

Duns Number: 429763668

Premarket Exempt : No

Product Code : IPF, KQX

Prescription Use : Yes

Device Count : 1

- Catalog Number : SPM01K1

Device Description : For the stand-alone mode version of the subject device, the SPM01K1 convenience For the stand-alone mode version of the subject device, the SPM01K1 convenience kit includes: 1 electrostimulator SPM01M1 configuration; electrodes, and protective skin.

Device Class : 1

Duns Number: 429763668

Premarket Exempt : No

Product Code : IPF, KQX

Prescription Use : Yes

Device Count : 1

- Catalog Number : SPM01K2

Device Description : For the wireless mode version of the subject device, to be used in combination w For the wireless mode version of the subject device, to be used in combination with a dedicated control software running on a pc/laptop, the content of the SPM01K2 convenience kit is: 1 electrostimulator SPM01M2 configuration; electrodes, and protective skin.

Device Class : 1

Duns Number: 429763668

Premarket Exempt : No

Product Code : IPF, KQX

Prescription Use : Yes

Device Count : 1

Device Description : For the wireless mode version of the subject device, to be used in combination w For the wireless mode version of the subject device, to be used in combination with an application installed on a tablet, the SPM01K3 convenience kit includes: 1 electrostimulator SPM01M1 configuration; electrodes; protective skin, and 1 tablet with the MySPM mobile application (SPM01A1).

Device Class : 1

Duns Number: 429763668

Premarket Exempt : No

Product Code : IPF, KQX

Prescription Use : Yes

Device Count : 1

Device Description : For the wireless mode version of the subject device, combined with an applicatio For the wireless mode version of the subject device, combined with an application installed on a tablet that can be used in a home environment, the content of the SPM01K4 convenience kit is: 1 electrostimulator SPM01M1 configuration; electrodes; protective skin, and 1 tablet with the MySPM@Home mobile application (SPM01A2).

Device Class : 1

Duns Number: 429763668

Premarket Exempt : No

Product Code : IPF, KQX

Prescription Use : Yes

Device Count : 1