Ellman International

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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, electrosurgical (JOS) (9) ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES (GEI) (1)

Premarket Exempt

No Yes

Clear

Triangle Loop Electrode - 00841494101312 Catalog Number : TC14B

Device Description : 3/8" TRIANGLE ELECTRODE REG WIRE, 1/16"

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 2

Needle Electrode - 00841494101329 Catalog Number : TA9B/4

Device Description : 3/8" NDLE ELEC 4" L BEND, REG WIRE, 1/16

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 2

Needle Electrode - 00841494101336 Catalog Number : TA1B

Device Description : 3/8" NDLE ELEC. SUPER FINE WIRE, 1/16"

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 2

Needle Electrode - 00841494101343 Catalog Number : TA3B/4

Device Description : 3/8" NDLE ELEC.1/32" DIA 4"L, BEND,1/16"

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 2

Needle Electrode - 00841494101350 Catalog Number : XA3B

Device Description : 3/8" NDLE ELECTRODE 1/32" DIA, BEND,1/16

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 5

Needle Electrode - 00841494101367 Catalog Number : QTA2B

Device Description : 3/8" NDLE ELECTRODE FINE WIRE BEND 3/32"

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 2

Needle Electrode - 00841494101374 Catalog Number : XA9B

Device Description : 3/8" NDLE ELECTRODE REG WIRE, BEND,1/16"

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 5

Needle Electrode - 00841494101381 Catalog Number : XA1B

Device Description : 3/8" NDLE ELECTRODE SUPER FINE WIRE,1/16

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 5

Ace-Tip Electrode - 00841494101398 Catalog Number : TNAA9B

Device Description : 3/8" NEEDLE ACE-TIP REGULAR WIRE, 1/16"

Device Class :

Duns Number: 079095245

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 2

Needle Electrode - 00841494101404 Catalog Number : TA3B

Device Description : 3/8" NEEDLE ELEC. 1/32" DIA. BEND, 1/16"

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 2

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