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

Electrosurgical, Cutting & Coagulation & Accessories (GEI) (9) Laparoscope, General & Plastic Surgery (GCJ) (3)

Premarket Exempt

No Yes

Clear

ELMED - 00842180141100 Catalog Number : 5-0524-29A

Device Description : 5MM, 24CM, CLEAR FLUSH, ALLIGATOR GRASPER, RETRO-FACING TEETH, DA, RADEL INSULAT 5MM, 24CM, CLEAR FLUSH, ALLIGATOR GRASPER, RETRO-FACING TEETH, DA, RADEL INSULATION, RIGID, ONE PIECE

Device Class : 2

Duns Number: 049290364

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

ELMED - 00842180141117 Catalog Number : 5-0533-29A

Device Description : 5MM, 33CM, CLEAR FLUSH, ALLIGATOR GRASPER, RETRO-FACING TEETH, DA, RADEL INSULAT 5MM, 33CM, CLEAR FLUSH, ALLIGATOR GRASPER, RETRO-FACING TEETH, DA, RADEL INSULATION, RIGID, ONE PIECE

Device Class : 2

Duns Number: 049290364

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

ELMED - 00842180141124 Catalog Number : 5-0536-29A

Device Description : 5MM, 36CM, CLEAR FLUSH, ALLIGATOR GRASPER, RETRO-FACING TEETH, DA, RADEL INSULAT 5MM, 36CM, CLEAR FLUSH, ALLIGATOR GRASPER, RETRO-FACING TEETH, DA, RADEL INSULATION, RIGID, ONE PIECE

Device Class : 2

Duns Number: 049290364

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

ELMED - 00842180141131 Catalog Number : 5-0545-29A

Device Description : 5MM, 45CM, CLEAR FLUSH, ALLIGATOR GRASPER, RETRO-FACING TEETH, DA, RADEL INSULAT 5MM, 45CM, CLEAR FLUSH, ALLIGATOR GRASPER, RETRO-FACING TEETH, DA, RADEL INSULATION, RIGID, ONE PIECE

Device Class : 2

Duns Number: 049290364

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

ELMED - 00842180141148 Catalog Number : 5-0524-129A

Device Description : 5MM, 24CM, CLEAR FLUSH, ALLIGATOR GRASPER, RETRO-FACING TEETH, DA, LONG, RADEL I 5MM, 24CM, CLEAR FLUSH, ALLIGATOR GRASPER, RETRO-FACING TEETH, DA, LONG, RADEL INSULATION, RIGID, ONE PIECE

Device Class : 2

Duns Number: 049290364

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

ELMED - 00842180141230 Catalog Number : 5990-10*

Device Description : ELMED BIPOLAR FORCEPS, 2-PIN CONNECTOR, HARDY BAYONET, 10 3/4" (25.5CM) INSULATE ELMED BIPOLAR FORCEPS, 2-PIN CONNECTOR, HARDY BAYONET, 10 3/4" (25.5CM) INSULATED, STRAIGHT TIP (*SPECIFY TIP SIZE)

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : GEI

Prescription Use : Yes

Device Count : 1

ELMED - 00842180142541 Catalog Number : 5-0524-60A

Device Description : 5MM, 24CM, CLEAR FLUSH, HOOK SCISSORS, SINGLE-ACTION, RADEL INSULATION, RIGID, ONE PIECE

Device Class : 2

Duns Number: 049290364

Premarket Exempt : No

Product Code : GCJ, GEI

Prescription Use : Yes

Device Count : 1

ELMED - 00842180142695 Catalog Number : 32-308-16I

Device Description : INSULATED DEBAKEY FORCEPS, 2.0MM TIP NON-INSULATED TIP 6"

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : GEI

Prescription Use : Yes

Device Count : 1

ELMED - 00842180143029 Catalog Number : 5-0524-70A

Device Description : 5MM, 24CM, CLEAR FLUSH, BIOPSY SPOON FORCEPS, DA, RADEL INSULATION, RIGID, ONE PIECE

Device Class : 2

Duns Number: 049290364

Premarket Exempt : No

Product Code : GEI, GCJ

Prescription Use : Yes

Device Count : 1

ELMED - 00842180143982 Catalog Number : 52515-71

Device Description : 5MM, 45CM NEEDLE HOLDER, CURVED LEFT TUNGSTEN CARBIDE TIP, ERGONOMIC CURVED DOWN 5MM, 45CM NEEDLE HOLDER, CURVED LEFT 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

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