ELMED INCORPORATED

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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

Laparoscope, General & Plastic Surgery (GCJ) (9) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (2)

Premarket Exempt

No Yes

Clear

ELMED - 00842180147430 Catalog Number : 52502-19A

Device Description : 5 MM DIA., 32 CM PETELIN DISSECTOR 60 DEGREE STAINLESS STEEL, - STANDARD HANDLE, 5 MM DIA., 32 CM PETELIN DISSECTOR 60 DEGREE STAINLESS STEEL, - STANDARD HANDLE, RIGID-ONE PIECE

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ELMED - 00842180147447 Catalog Number : 52105-100S

Device Description : 5 MM DIA., 45 CM KLEPPINGER, SYRINGE TYPE, BIPOLAR FORCEPS, STANDARD TIP(S) FENE 5 MM DIA., 45 CM KLEPPINGER, SYRINGE TYPE, BIPOLAR FORCEPS, STANDARD TIP(S) FENESTRATED W/ WAVE FOR SECURE GRIP

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ELMED - 00842180147454 Catalog Number : 52255-204B*

Device Description : 5MM, 33CM MICRO BULLET-NOSE GRASPER W/ SPOON, ROTATABLE, ONE PIECE W/ FLUSHPORT, 5MM, 33CM MICRO BULLET-NOSE GRASPER W/ SPOON, ROTATABLE, ONE PIECE W/ FLUSHPORT, SELECT HANDLE TYPE, INSULATED STAINLESS STEEL W/ RF POST

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : GCJ, GEI

Prescription Use : Yes

Device Count : 1

ELMED - 00842180147461 Catalog Number : 52320-26

Device Description : INSULATED SUCTION TIP ELECTRODE

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : GEI

Prescription Use : Yes

Device Count : 1

ELMED - 00842180147478 Catalog Number : 52730-403

Device Description : 3MM, 30CM, IRRIGATION / SUCTION TUBE FOR DISPOSABLE HANDLES REGULAR TIP-VENTED, 3MM, 30CM, IRRIGATION / SUCTION TUBE FOR DISPOSABLE HANDLES REGULAR TIP-VENTED, STAINLESS STEEL FINISH - STRYKER

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ELMED - 00842180147485 Catalog Number : 53020-66IT

Device Description : 3MM, 20CM METZENBAUM SCISSORS, CURVED, INSERT & TUBE

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ELMED - 00842180147492 Catalog Number : 53020-06IT

Device Description : 3MM, 20CM INSERT & TUBE, MARYLAND DISSECTOR

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ELMED - 00842180147508 Catalog Number : 53020-11IT

Device Description : 3MM, 20 CM INSERT & TUBE, KELLY DISSECTOR

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ELMED - 00842180147515 Catalog Number : 53020-03IT

Device Description : 3.5MM, 20CM STANDARD GRASPER

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ELMED - 00842180147522 Catalog Number : 53020-16IT

Device Description : 3MM, 20CM INSERT & TUBE, BABCOCK DISSECTOR

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

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