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) (8) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (5)

Premarket Exempt

No Yes

Clear

ELMED - 00842180147669 Catalog Number : 52255-158C*

Device Description : 5MM, 33CM, HUNDER DEBAKEY FENESTRATED 16MM TIP, 3-PIECE, MODULAR, SCREW APART, S 5MM, 33CM, HUNDER DEBAKEY FENESTRATED 16MM TIP, 3-PIECE, MODULAR, SCREW APART, SELECT HANDLE TYPE: LIGHTWEIGHT CARBON-FIBER W/ RF POST RATCHET / RATCHET DEFEATING W LARGE FINGER LOOPS

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : GCJ, GEI

Prescription Use : Yes

Device Count : 1

ELMED - 00842180147690 Catalog Number : 53530-66IT

Device Description : 3MM 30CM, METZ SCISSORS, CURVED, INSERT & TUBE

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ELMED - 00842180147706 Catalog Number : 52236-222B*

Device Description : 5MM, 36CM, DEBAKEY GRASPER, SINGLE ACTION, 22MM JAW, ROTATABLE, ONE PIECE W/ FLU 5MM, 36CM, DEBAKEY GRASPER, SINGLE ACTION, 22MM JAW, ROTATABLE, ONE PIECE W/ FLUSHPORT, SELECT HANDLE TYPE

Device Class : 2

Duns Number: 049290364

Premarket Exempt : No

Product Code : GEI, GCJ

Prescription Use : Yes

Device Count : 1

ELMED - 00842180147713 Catalog Number : 5717-05

Device Description : KNIFE BLADE ELECTRODE REUSABLE FOR 2MM HANDLES ROUND TIP

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : GEI

Prescription Use : Yes

Device Count : 1

ELMED - 00842180150560 Catalog Number : 5592-08B-ST

Device Description : BIPOLAR FORCEPS, 9" (22MM), HARDY BAYONET W/ IRRIGATION, NON-INSULATED W/ STRAIG BIPOLAR FORCEPS, 9" (22MM), HARDY BAYONET W/ IRRIGATION, NON-INSULATED W/ STRAIGHT TIP & STOP

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ELMED - 00842180150577 Catalog Number : 52205-35-28

Device Description : MONOPOLAR INSULATED KNIFE ELECTRODE, 3.5MM X 28CM, REAR MOUNT RF CONNECTOR

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : GCJ, GEI

Prescription Use : Yes

Device Count : 1

ELMED - 00842180150584 Catalog Number : 52501-01A

Device Description : 5MM 45CM HOOK SCISSORS, STAINLESS STEEL, NON-ROTATING, STANDARD HANDLE

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ELMED - 00842180150591 Catalog Number : 52505-72

Device Description : 5 MM DIA., 32 CM, NEEDLE HOLDER (KOH MACRO) CURVED RIGHT TUNGSTEN CARBIDE TIP (6 5 MM DIA., 32 CM, NEEDLE HOLDER (KOH MACRO) CURVED RIGHT TUNGSTEN CARBIDE TIP (6 MM LENGTH), ERGONOMIC CURVED DOWN AXIAL HANDLE WITH RATCHET, FLUSH PORT

Device Class : 2

Duns Number: 049290364

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ELMED - 00842180150607 Catalog Number : 52237-58B*

Device Description : 5MM, 37CM, DOUBLE ACTION HUNTER DEBAKEY GRASPER, 20MM, INSULATED SHAFT, ROTATABL 5MM, 37CM, DOUBLE ACTION HUNTER DEBAKEY GRASPER, 20MM, INSULATED SHAFT, ROTATABLE W/ FLUSHPORT, SELECT HANDLE TYPE

Device Class : 2

Duns Number: 049290364

Premarket Exempt : No

Product Code : GCJ, GEI

Prescription Use : Yes

Device Count : 1

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