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 - 00841494101114 Catalog Number : TC11B

Device Description : 19/64" TRIANGLE ELECTRO FINE WIRE, 1/16"

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 2

IEC 1-Buttom Fingerswitch Handpiece - 00841494101121 Catalog Number : IEC-X1FHPA

Device Description : 1-BUTTON FSHP W/LCK CHUCK,REUSABLE (2PC)

Device Class : 2

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 1

1-BUTTON Fingerswitch Handpiece - 00841494101138 Catalog Number : IEC-1FHPA

Device Description : 1-BUTTON FSHP,LOCKING CHUCK,REUSABLE 1PC

Device Class : 2

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 1

Ace-Tip Electrode - 00841494101145 Catalog Number : TNAEE287

Device Description : 1CM NEEDLE, 3"CURVED SLEEVE ACE-TIP,1/16

Device Class :

Duns Number: 079095245

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 2

Ball Electrode - 00841494101152 Catalog Number : XD8B

Device Description : 2.36MM BALL ELECTRODE BENDABLE, 1/16"

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 5

Lap Trode - 00841494101169 Catalog Number : L6

Device Description : 2.3MM BLADE LAP-TRODE 37.5CM, 1/16"SHAFT

Device Class : 2

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 1

Ball Electrode - 00841494101176 Catalog Number : TD3B/4

Device Description : 2MM BALL ELECTRODE - 4" BENDABLE, 1/16"

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 2

Ball Electrode - 00841494101183 Catalog Number : TD8B/4

Device Description : 2MM BALL ELECTRODE 4" L BENDABLE, 1/16"

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 2

Ball Electrode - 00841494101190 Catalog Number : TD8B

Device Description : 2MM BALL ELECTRODE BENDABLE, 1/16"

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 2

Ball Electrode - 00841494101206 Catalog Number : TD3B

Device Description : 2MM BALL ELECTRODE BENDABLE, 1/16"

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 2

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