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) (8) ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES (GEI) (2)

Premarket Exempt

No Yes

Clear

Triangle Loop Electrode - 00841494100810 Catalog Number : TC8B

Device Description : 1/4" TRIANGLE ELECTRODE REG WIRE, 1/16"

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 2

Triangle Loop Electrode - 00841494100827 Catalog Number : TC7B/4

Device Description : 1/4" TRIANGLE FINE WIRE, 4" LONG, BEND.

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 2

Diamond Loop Electrode - 00841494100834 Catalog Number : TC17B

Device Description : 1/4" 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 - 00841494100841 Catalog Number : TC18B

Device Description : 1/4" 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 - 00841494100858 Catalog Number : TC17B/4

Device Description : 1/4" DIAMOND LOOP, 4" L, FINE WIRE, 1/16

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 2

#108 Electrode - 00841494100865 Catalog Number : T108B

Device Description : 1/4" LOOP, REG WIRE 1/16" SHAFT ( 2 PK )

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 2

Oval Loop Electrode - 00841494100872 Catalog Number : TP3B

Device Description : 1/4" OVAL LOOP ELECTRODE FINE WIRE, 1/16

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 2

Oval Loop Electrode - 00841494100889 Catalog Number : TP4B

Device Description : 1/4" OVAL LOOP ELECTRODE REG WIRE, 1/16"

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 2

Ace-Tip Electrode - 00841494100896 Catalog Number : TNAB1B

Device Description : 1/4" RND LOOP ACE-TIP FINE WIRE, 1/16"

Device Class :

Duns Number: 079095245

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 2

Ace-Tip Electrode - 00841494100902 Catalog Number : TNAB4B

Device Description : 1/4" RND LOOP ACE-TIP REGULAR WIRE, 1/16

Device Class :

Duns Number: 079095245

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 2

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