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) (6) ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES (GEI) (2) Electrosurgical patient return electrode (ODR) (1) SPECULUM, VAGINAL, METAL (HDF) (1)

Premarket Exempt

No Yes

Clear

Cosmetic Treatment Package - 00841494107079 Catalog Number : H135A

Device Description : COSMETIC TREATMENT PACKAGE FOR EMC

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 51

Vaginal Retractor - 00841494107093 Catalog Number : H69

Device Description : VAGINAL LATERAL WALL RETRACTOR

Device Class : 1

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : HDF

Prescription Use : Yes

Device Count : 1

3 Button FSHP - 00841494107109 Catalog Number : IEC-3FHPB/D1

Device Description : STERILE 3-BUTTON FSHP, LOCKING CHUCK 1PC

Device Class : 2

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 1

Bipolar Cable - 00841494107116 Catalog Number : IEC-BIUC

Device Description : BIPOLAR CABLE

Device Class : 2

Duns Number: 079095245

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

YABE Electrode - 00841494107123 Catalog Number : IEC-EE239

Device Description : YABE MYRINGOTOMY ELECTRODE W SUCTION PCK

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 2

Neutral Pad - 00841494107130 Catalog Number : IEC-NPD1

Device Description : IEC NEUTRAL PAD, DISPOSABLE, 1/PKG

Device Class : 2

Duns Number: 079095245

Premarket Exempt : No

Product Code : ODR

Prescription Use : Yes

Device Count : 1

Pelleve Quick-Connect Cable - 00841494107154 Catalog Number : P2CBD

Device Description : Pelleve Quick-Connect Cable

Device Class : 2

Duns Number: 079095245

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Round Loop Electrode - 00841494107161 Catalog Number : TB2B/4

Device Description : 3/8" RND LOOP ELEC. 4"L FINE WIRE, 1/16"

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 2

Diamond Electrode - 00841494107178 Catalog Number : TC18B/4

Device Description : 1/4" DIAMOND ELEC REG.WIRE, 1/16", 4" L.

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 2

Diamond Electrode - 00841494107185 Catalog Number : TC4B

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

Device Class :

Duns Number: 079095245

Premarket Exempt : Yes

Product Code : JOS

Prescription Use : Yes

Device Count : 2

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