SALUDA MEDICAL PTY LIMITED

Address:407 Pacific Highway,Artarmon New South Wales,AU

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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

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief (LGW) (10)

Premarket Exempt

Clear

Evoke® Pocket Console (EPC) - 09352307000025 Catalog Number : 3040

Device Class : 3

Duns Number: 744596461

Premarket Exempt : No

Product Code : LGW

Prescription Use : Yes

Device Count : 1

Evoke® Clinical System Transceiver (CST) - 09352307000049 Catalog Number : 3004

Device Class : 3

Duns Number: 744596461

Premarket Exempt : No

Product Code : LGW

Prescription Use : Yes

Device Count : 1

Evoke® Charger - 09352307000063 Catalog Number : 3006

Device Class : 3

Duns Number: 744596461

Premarket Exempt : No

Product Code : LGW

Prescription Use : Yes

Device Count : 1

Evoke® 12C Percutaneous Lead Kit - 60 cm - 09352307000087 Catalog Number : 3008

Device Class : 3

Duns Number: 744596461

Premarket Exempt : No

Product Code : LGW

Prescription Use : Yes

Device Count : 1

Evoke® 12C Percutaneous Lead Kit - 90 cm - 09352307000100 Catalog Number : 3009

Device Class : 3

Duns Number: 744596461

Premarket Exempt : No

Product Code : LGW

Prescription Use : Yes

Device Count : 1

Evoke® Tunnelling Tool - 09352307000131 Catalog Number : 3012

Device Class : 3

Duns Number: 744596461

Premarket Exempt : No

Product Code : LGW

Prescription Use : Yes

Device Count : 1

Evoke® Epidural Needle 6.5" - 09352307000155 Catalog Number : 3014

Device Class : 3

Duns Number: 744596461

Premarket Exempt : No

Product Code : LGW

Prescription Use : Yes

Device Count : 1

Evoke® Spares Kit - 09352307000179 Catalog Number : 3015

Device Class : 3

Duns Number: 744596461

Premarket Exempt : No

Product Code : LGW

Prescription Use : Yes

Device Count : 1

Evoke® 12C Percutaneous Trial Lead Kit - 60 cm - 09352307000193 Catalog Number : 3016

Device Class : 3

Duns Number: 744596461

Premarket Exempt : No

Product Code : LGW

Prescription Use : Yes

Device Count : 1

Evoke® Clinical Interface (CI) - 09352307000230 Catalog Number : 3024

Device Class : 3

Duns Number: 744596461

Premarket Exempt : No

Product Code : LGW

Prescription Use : Yes

Device Count : 1

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