DIXI MEDICAL

Address:2A ROUTE DE POULIGNEY CHAUDEFONTAINE,MARCHAUX-CHAUDEFONTAINE Doubs,FR

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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

Electrode, Depth (GZL) (8) Electrode, Cortical (GYC) (1) Instrument, Surgical, Non-Powered (HAO) (1)

Premarket Exempt

No Yes

Clear

NA - 03664539002743 Catalog Number : KIP-ACS-513

Device Description : TWIST DRILL FOR ANCHOR BOLT, SQUARE SHANK, LENGTH 124MM, ACCESSORY OF MICRODEEP TWIST DRILL FOR ANCHOR BOLT, SQUARE SHANK, LENGTH 124MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE

Device Class : 2

Duns Number: 268009609

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

NA - 03664539002774 Catalog Number : KIP-ACS-515

Device Description : TWIST DRILL FOR ANCHOR BOLT, LENGTH 200MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE

Device Class : 2

Duns Number: 268009609

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

NA - 03664539002781 Catalog Number : KIP-ACS-516

Device Description : TWIST DRILL FOR ANCHOR BOLT, HEXAGONAL SHANK, LENGTH 157MM, ACCESSORY OF MICRODE TWIST DRILL FOR ANCHOR BOLT, HEXAGONAL SHANK, LENGTH 157MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE

Device Class : 2

Duns Number: 268009609

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

NA - 03664539002798 Catalog Number : KIP-ACS-517

Device Description : TWIST DRILL FOR ANCHOR BOLT, QUICK LOCKING SHANK, LENGTH 192MM, ACCESSORY OF MIC TWIST DRILL FOR ANCHOR BOLT, QUICK LOCKING SHANK, LENGTH 192MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE

Device Class : 2

Duns Number: 268009609

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

NA - 03664539002804 Catalog Number : KIP-ACS-518

Device Description : TWIST DRILL FOR ANCHOR BOLT, HEXAGONAL SHANK, LENGTH 190MM, ACCESSORY OF MICRODE TWIST DRILL FOR ANCHOR BOLT, HEXAGONAL SHANK, LENGTH 190MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE

Device Class : 2

Duns Number: 268009609

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

NA - 03664539002811 Catalog Number : KIP-ACS-519

Device Description : TWIST DRILL FOR ANCHOR BOLT, HEXAGONAL SHANK, LENGTH 160MM, ACCESSORY OF MICRODE TWIST DRILL FOR ANCHOR BOLT, HEXAGONAL SHANK, LENGTH 160MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE

Device Class : 2

Duns Number: 268009609

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

NA - 03664539002910 Catalog Number : KIP-ACS-600

Device Description : COAGULATION ELECTRODE FOR DURA, ACCESSORY OF MICRODEEP DEPTH ELECTRODE

Device Class : 2

Duns Number: 268009609

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

NA - 03664539002927 Catalog Number : KIP-ACS-605

Device Description : COAGULATION ELECTRODE FOR SCALP, ACCESSORY OF MICRODEEP DEPTH ELECTRODE

Device Class : 2

Duns Number: 268009609

Premarket Exempt : No

Product Code : GZL

Prescription Use : Yes

Device Count : 1

NA - 03664539003047 Catalog Number : C10-16CIOM

Device Description : SUBDURAL ELECTRODE WITH CONNECTION CABLE, GRID, 4x4 CONTACTS

Device Class : 2

Duns Number: 268009609

Premarket Exempt : No

Product Code : GYC

Prescription Use : Yes

Device Count : 1

NA - 03664539003405 Catalog Number : ACS-SG1S-5

Device Description : SET OF 10 WIRE GUIDES, ACCESSORY OF MICRODEEP MICRO-MACRO DEPTH ELECTRODE

Device Class : 1

Duns Number: 268009609

Premarket Exempt : Yes

Product Code : HAO

Prescription Use : Yes

Device Count : 5

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