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) (4)

Premarket Exempt

No Yes

Clear

ELMED - 00842180147539 Catalog Number : 53020-67IT

Device Description : PERITONAL SCISSOR, SINGLE ACTION

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ELMED - 00842180147546 Catalog Number : 53020-14IT

Device Description : MICRO GRASPER / DISSECTOR FENESTRATED

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ELMED - 00842180147553 Catalog Number : 83-90-3026

Device Description : 5MM, 33CM CUSTOM BABCOCK GRASPER

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ELMED - 00842180147591 Catalog Number : 52155-41D*

Device Description : 5MM DIA., 45CM, JOHAN FENESTRATED GRASPER, 20MM TIP, 3-PIECE MODULAR, SCREW APAR 5MM DIA., 45CM, JOHAN FENESTRATED GRASPER, 20MM TIP, 3-PIECE MODULAR, SCREW APART, NON-ROTATABLE, *SELECT HANDLE TYPE

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : GCJ, GEI

Prescription Use : Yes

Device Count : 1

ELMED - 00842180147607 Catalog Number : 52236-64

Device Description : 5MM, 36CMM INSULATED SPATULA, WITH TRUMPET VALVE CONNECTION & SIDE RF POST

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : GEI

Prescription Use : Yes

Device Count : 1

ELMED - 00842180147614 Catalog Number : 52536-70P

Device Description : 5MM 36CM NEEDLE HOLDER, STRAIGHT 8 MM TC TIP, THERMO-PLASTIC AXIAL HANDLE, CURVE 5MM 36CM NEEDLE HOLDER, STRAIGHT 8 MM TC TIP, THERMO-PLASTIC AXIAL HANDLE, CURVED DOWN W/RATCHET

Device Class : 2

Duns Number: 049290364

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ELMED - 00842180147621 Catalog Number : 52515-70P

Device Description : 5MM 45CM NEEDLE HOLDER, STRAIGHT TUNGSTEN CARBIDE TIP, ERGONOMIC CURVED DOWN SIN 5MM 45CM NEEDLE HOLDER, STRAIGHT TUNGSTEN CARBIDE TIP, ERGONOMIC CURVED DOWN SINGLE ACTION AXIAL HANDLE W/ RATCHET, FLUSHPORT

Device Class : 2

Duns Number: 049290364

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ELMED - 00842180147638 Catalog Number : 52636-159B

Device Description : 5MM DIA., 36 CM, HUNTER BOWEL GRASPER, 40 MM JAW, FENESTRATED JAW W/ DEBAKEY-TYP 5MM DIA., 36 CM, HUNTER BOWEL GRASPER, 40 MM JAW, FENESTRATED JAW W/ DEBAKEY-TYPE TEETH FOR ATRAUMATIC MANIPULATION OF DELICATE TISSUE E.G. BOWEL, STOMACH; DOUBLE-ACTION, INSULATED SHAFT, SLIDE-LOCK HANDLE, ROTATABLE ONE-PIECE (B)

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

ELMED - 00842180147645 Catalog Number : 52101-20B*

Device Description : 10MM, 45CM ANVIL GRASPER TO GRASP & HOLD ANVIL CIRCULAR STAPLER ROTATABLE, ONE P 10MM, 45CM ANVIL GRASPER TO GRASP & HOLD ANVIL CIRCULAR STAPLER ROTATABLE, ONE PIECE W/ FLUSHPORT, *SELECT HANDLE TYPE

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : GCJ, GEI

Prescription Use : Yes

Device Count : 1

ELMED - 00842180147652 Catalog Number : 5950-07G

Device Description : ELMED BIPOLAR FORCEPS, 5 3/4 (14.5 CM), YASARGIL BAYONET, INSULATED w/ STRAIGHT ELMED BIPOLAR FORCEPS, 5 3/4 (14.5 CM), YASARGIL BAYONET, INSULATED w/ STRAIGHT TIP, NON-STICK TIP G, 0.6MM

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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