SGM d.o.o.

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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

Electrode, Needle (GXZ) (4) Electrode, Needle, Diagnostic Electromyograph (IKT) (1)

Premarket Exempt

Clear

Corkscrew Electrode - 00852373007021 Catalog Number : 003-400000-6

Device Description : Corkscrew Electrode CS-F (1,0m) 003-400000-6. Six packed individual inside one p Corkscrew Electrode CS-F (1,0m) 003-400000-6. Six packed individual inside one package to preserve sterility of the product. Used as a set for one medical operation.

Device Class :

Duns Number: 499490357

Premarket Exempt : No

Product Code : GXZ

Prescription Use : No

Device Count : 6

Corkscrew Electrode - 00852373007052 Catalog Number : 003-400001-6

Device Description : Corkscrew Electrode CS-F (1,5m) 003-400001-6. Six packed individual inside one Corkscrew Electrode CS-F (1,5m) 003-400001-6. Six packed individual inside one package of 6 to preserve sterility of the product. Used as a set for one operation.

Device Class :

Duns Number: 499490357

Premarket Exempt : No

Product Code : GXZ

Prescription Use : No

Device Count : 6

Twisted Pair Needle Electrode - 00852373007083 Catalog Number : 003-400124-3

Device Description : Twisted Pair Needle Electrode TPN-F (2,0m) L12mm 003-400124-3 Three units of Twisted Pair Needle Electrode TPN-F (2,0m) L12mm 003-400124-3 Three units of paired electrodes packaged individual, inside one package, to preserve sterility of the product. Used as a set for one medical operation.

Device Class :

Duns Number: 499490357

Premarket Exempt : No

Product Code : IKT

Prescription Use : No

Device Count : 3

Corkscrew Electrode - 00852373007199 Catalog Number : 003-400001-5

Device Description : Corkscrew electrode CS-F (2m) 003-400001-5. Five twisted electrodes in double p Corkscrew electrode CS-F (2m) 003-400001-5. Five twisted electrodes in double package to preserve sterility of the product. Use for one medical operation.

Device Class :

Duns Number: 499490357

Premarket Exempt : No

Product Code : GXZ

Prescription Use : No

Device Count : 5

Corkscew Electrode - 00852373007229 Catalog Number : 003-400001-4

Device Description : Corkscrew electrode CS-F (2m) 003-400001-4. Four twisted electrodes in double pa Corkscrew electrode CS-F (2m) 003-400001-4. Four twisted electrodes in double package to preserve sterility of the product. Use for one medical operation.

Device Class :

Duns Number: 499490357

Premarket Exempt : No

Product Code : GXZ

Prescription Use : No

Device Count : 4

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