NCS LAB SRL

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

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Exerciser, Measuring (ISD) (8) Orthopedic Manual Surgical Instrument (LXH) (2)

Premarket Exempt

No Yes

Clear

GT TUNNELER - 08051122040988 Catalog Number :

Device Description : GT TUNNELER is a sterile, single-use device used in standard shoulder arthroscop GT TUNNELER is a sterile, single-use device used in standard shoulder arthroscopy procedures.

Device Class : 1

Duns Number: 429763668

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

GT TUNNELER KIT - 08051122040995 Catalog Number :

Device Description : GT TUNNELER device and non-adsorbable sutures.

Device Class : 1

Duns Number: 429763668

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

WISE (wireless inertial sensor equipment) - 08051122041008 Catalog Number :

Device Description : The WISE is a magnetic and inertial unit including 3D accelerometers, gyroscopes The WISE is a magnetic and inertial unit including 3D accelerometers, gyroscopes and magnetometers.

Device Class : 2

Duns Number: 429763668

Premarket Exempt : Yes

Product Code : ISD

Prescription Use : Yes

Device Count : 1

Gateway - 08051122041015 Catalog Number :

Device Description : The GATEWAY is a 2.4 GHz wireless receiver that communicates with the WISE inert The GATEWAY is a 2.4 GHz wireless receiver that communicates with the WISE inertial sensor.

Device Class : 2

Duns Number: 429763668

Premarket Exempt : Yes

Product Code : ISD

Prescription Use : Yes

Device Count : 1

UPPER LIMB KIT – 5 WISE - 08051122041022 Catalog Number :

Device Description : The Showmotion UPPER 5 kit includes 5 WISE sensors, a GATEWAY receiver, elastic The Showmotion UPPER 5 kit includes 5 WISE sensors, a GATEWAY receiver, elastic bands and a charger.The platform allows to carry out the kinematic analysis of the movement of the upper district.

Device Class : 2

Duns Number: 429763668

Premarket Exempt : Yes

Product Code : ISD

Prescription Use : Yes

Device Count : 1

UPPER LIMB KIT – 7 WISE - 08051122041039 Catalog Number :

Device Description : The Showmotion UPPER 7 kit includes 7 WISE sensors, a GATEWAY receiver, elastic The Showmotion UPPER 7 kit includes 7 WISE sensors, a GATEWAY receiver, elastic bands and a charger.The platform allows to carry out the kinematic analysis of the movement of the upper district.

Device Class : 2

Duns Number: 429763668

Premarket Exempt : Yes

Product Code : ISD

Prescription Use : Yes

Device Count : 1

LOWER LIMB KIT – 6 WISE - 08051122041046 Catalog Number :

Device Description : The Showmotion LOWER 6 kit includes 6 WISE sensors, a GATEWAY receiver, elastic The Showmotion LOWER 6 kit includes 6 WISE sensors, a GATEWAY receiver, elastic bands and a charger.The platform allows to carry out the kinematic analysis of the movement of the lower district.

Device Class : 2

Duns Number: 429763668

Premarket Exempt : Yes

Product Code : ISD

Prescription Use : Yes

Device Count : 1

LOWER LIMB KIT – 8 WISE - 08051122041053 Catalog Number :

Device Description : The Showmotion LOWER 8 kit includes 8 WISE sensors, a GATEWAY receiver, elastic The Showmotion LOWER 8 kit includes 8 WISE sensors, a GATEWAY receiver, elastic bands and a charger.The platform allows to carry out the kinematic analysis of the movement of the lower district.

Device Class : 2

Duns Number: 429763668

Premarket Exempt : Yes

Product Code : ISD

Prescription Use : Yes

Device Count : 1

TOTAL BODY KIT – 12 WISE - 08051122041060 Catalog Number :

Device Description : The Showmotion TOTAL 12 kit includes 12 WISE sensors, a GATEWAY receiver, elasti The Showmotion TOTAL 12 kit includes 12 WISE sensors, a GATEWAY receiver, elastic bands and a charger. The platform allows to carry out the kinematic analysis of the movement of the total body.

Device Class : 2

Duns Number: 429763668

Premarket Exempt : Yes

Product Code : ISD

Prescription Use : Yes

Device Count : 1

SPINE KIT – 2 WISE - 08051122041077 Catalog Number :

Device Description : The Showmotion SPINE 2 kit includes 2 WISE sensors, a GATEWAY receiver, elastic The Showmotion SPINE 2 kit includes 2 WISE sensors, a GATEWAY receiver, elastic bands and a charger. The platform allows to carry out the kinematic analysis of the movement of the spine.

Device Class : 2

Duns Number: 429763668

Premarket Exempt : Yes

Product Code : ISD

Prescription Use : Yes

Device Count : 1

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