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

Ball Electrode - 00841494101213 Catalog Number : XD3B

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

Lap Trode - 00841494101220 Catalog Number : L3

Device Description : 2MM BALL LAP-TRODE 37.5CM , 1/16" SHAFT

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 2

Ace-Tip Electrode - 00841494101237 Catalog Number : TNAD3B

Device Description : 2MM COAGULATING BALL ACE-TIP 1/16", BEND

Device Class :

Duns Number: 079095245

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 2

Ophthalmic Micro-Dissection - 00841494101244 Catalog Number : TA10/C2

Device Description : 3.0MM OPHTH. .004 FINE WIRE,1/16" -2PCS

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 2

Ball Electrode - 00841494101251 Catalog Number : XD9B

Device Description : 3.17MM BALL ELECTRODE BENDABLE, 1/16"

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 5

SCALPEL ELECTRODE - 00841494101268 Catalog Number : TE1B

Device Description : 3/16 SCALPEL ELECTRODE 45DEG ANGLE, 1/16

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 2

Diamond Loop Electrode - 00841494101275 Catalog Number : TC3B

Device Description : 3/16" DIAMOND ELECTRODE FINE WIRE, 1/16

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 2

Diamond Loop Electrode - 00841494101282 Catalog Number : TC6B

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

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 2

Diamond Loop Electrode - 00841494101299 Catalog Number : TC3B/4

Device Description : 3/16" ELECTRODE, 4"LONG, FINE WIRE,1/16"

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 2

Needle Electrode - 00841494101305 Catalog Number : A3D/OS

Device Description : 3/4" STRAIGHT NEEDLE STERILE, SINGLE-USE

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 25

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