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

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES (GEI) (4) Electrode, electrosurgical (JOS) (3) POST, ROOT CANAL (ELR) (2) Tourniquet kit (OJS) (1)

Premarket Exempt

No Yes

Clear

Bipolar Cord - 00841494106928 Catalog Number : IEC-JX/B

Device Description : IEC BIPOLAR CORD

Device Class : 2

Duns Number: 079095245

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Monoploar Cable - 00841494106935 Catalog Number : IEC-UC

Device Description : LAP-ENDO MONOPOLAR CABLE REUSABLE

Device Class : 2

Duns Number: 079095245

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bipolar Cable - 00841494106942 Catalog Number : IEC-BC

Device Description : MINOR SURGERY BIPOLAR CABLE STERILE,5PCS

Device Class :

Duns Number: 079095245

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 5

Snare Cable - 00841494106966 Catalog Number : H7B

Device Description : SNARE CABLE

Device Class : 2

Duns Number: 079095245

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Dental Elec. Set - 00841494107000 Catalog Number : DDS35

Device Description : DENTAL ELEC. ASSORTMENT 35 STERILE,1/16"

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 35

Triangle Electrode - 00841494107017 Catalog Number : TC10B/4

Device Description : 5/32" TRIANGLE ELEC. 4"L. REG WIRE, 1/16

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 2

Ellman Cots - 00841494107031 Catalog Number : ECOTS

Device Description : COTS - DIGIT TOURNIQUET 4 EA. S, M, L

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : OJS

Prescription Use : Yes

Device Count : 12

YABE Electrode - 00841494107048 Catalog Number : EE239

Device Description : YABE MYRINGOTOMY ELEC W SUCTION PACKAGE

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 2

Glass Fibre Post Kit - 00841494107055 Catalog Number : EGF200

Device Description : ELLMAN'S GLASS FIBRE POST KIT

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 28

Nubond Post Kit - 00841494107062 Catalog Number : EPO165

Device Description : NUBOND POST KIT

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : ELR

Prescription Use : Yes

Device Count : 42

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