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

Unit, Electrosurgical Andcoagulation, With Accessories (BWA) (10)

Premarket Exempt

Yes No

Clear

ELMED - 00842180100305 Catalog Number : 5513-10

Device Description : ELMED BIPOLAR FORCEPS, 2-PIN CONNECTOR, CUSHING BAYONET W/IRRIGATION, 10 3/4" (2 ELMED BIPOLAR FORCEPS, 2-PIN CONNECTOR, CUSHING BAYONET W/IRRIGATION, 10 3/4" (25.5CM) NON-INSULATED, ANGLED TIP, (*SPECIFY TIP SIZE, A - 2.0 MM, B - 1.5 MM, C - 1.0 MM, D - 0.5 MM, E - NEEDLE)

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : BWA

Prescription Use : Yes

Device Count : 1

ELMED - 00842180100312 Catalog Number : 5540-06

Device Description : ELMED BIPOLAR FORCEPS, 2-PIN CONNECTOR, SCOVILLE-GREENWOOD BAYONET W/IRRIGATION, ELMED BIPOLAR FORCEPS, 2-PIN CONNECTOR, SCOVILLE-GREENWOOD BAYONET W/IRRIGATION, 6 3/4" (15CM) INSULATED, STRAIGHT TIP, (*SPECIFY TIP SIZE, A - 2.0 MM, B - 1.5 MM, C - 1.0 MM, D - 0.5 MM, E - NEEDLE)

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : BWA

Prescription Use : Yes

Device Count : 1

ELMED - 00842180100329 Catalog Number : 5540-07

Device Description : ELMED BIPOLAR FORCEPS, 2-PIN CONNECTOR, SCOVILLE-GREENWOOD BAYONET W/IRRIGATION, ELMED BIPOLAR FORCEPS, 2-PIN CONNECTOR, SCOVILLE-GREENWOOD BAYONET W/IRRIGATION, 7 3/4" (18CM) INSULATED, STRAIGHT TIP, (*SPECIFY TIP SIZE, A - 2.0 MM, B - 1.5 MM, C - 1.0 MM, D - 0.5 MM, E - NEEDLE)

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : BWA

Prescription Use : Yes

Device Count : 1

ELMED - 00842180100336 Catalog Number : 5540-08

Device Description : ELMED BIPOLAR FORCEPS, 2-PIN CONNECTOR, SCOVILLE-GREENWOOD BAYONET W/IRRIGATION, ELMED BIPOLAR FORCEPS, 2-PIN CONNECTOR, SCOVILLE-GREENWOOD BAYONET W/IRRIGATION, 8 3/4" (20CM) INSULATED, STRAIGHT TIP, (*SPECIFY TIP SIZE, A - 2.0 MM, B - 1.5 MM, C - 1.0 MM, D - 0.5 MM, E - NEEDLE)

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : BWA

Prescription Use : Yes

Device Count : 1

ELMED - 00842180100343 Catalog Number : 5542-06

Device Description : ELMED BIPOLAR FORCEPS, 2-PIN CONNECTOR, SCOVILLE-GREENWOOD BAYONET W/IRRIGATION, ELMED BIPOLAR FORCEPS, 2-PIN CONNECTOR, SCOVILLE-GREENWOOD BAYONET W/IRRIGATION, 6 3/4" (15CM) NON-INSULATED, STRAIGHT TIP, (*SPECIFY TIP SIZE, A - 2.0 MM, B - 1.5 MM, C - 1.0 MM, D - 0.5 MM, E - NEEDLE)

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : BWA

Prescription Use : Yes

Device Count : 1

ELMED - 00842180100350 Catalog Number : 5542-07

Device Description : ELMED BIPOLAR FORCEPS, 2-PIN CONNECTOR, SCOVILLE-GREENWOOD BAYONET W/IRRIGATION, ELMED BIPOLAR FORCEPS, 2-PIN CONNECTOR, SCOVILLE-GREENWOOD BAYONET W/IRRIGATION, 7 3/4" (18CM) NON-INSULATED, STRAIGHT TIP, (*SPECIFY TIP SIZE, A - 2.0 MM, B - 1.5 MM, C - 1.0 MM, D - 0.5 MM, E - NEEDLE)

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : BWA

Prescription Use : Yes

Device Count : 1

ELMED - 00842180100367 Catalog Number : 5542-08

Device Description : ELMED BIPOLAR FORCEPS, 2-PIN CONNECTOR, SCOVILLE-GREENWOOD BAYONET W/IRRIGATION, ELMED BIPOLAR FORCEPS, 2-PIN CONNECTOR, SCOVILLE-GREENWOOD BAYONET W/IRRIGATION, 8 3/4" (20CM) NON-INSULATED, STRAIGHT TIP, (*SPECIFY TIP SIZE, A - 2.0 MM, B - 1.5 MM, C - 1.0 MM, D - 0.5 MM, E - NEEDLE)

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : BWA

Prescription Use : Yes

Device Count : 1

ELMED - 00842180100374 Catalog Number : 5550-06

Device Description : ELMED BIPOLAR FORCEPS, 2-PIN CONNECTOR, YASARGIL BAYONET W/IRRIGATION, 6 1/4" (1 ELMED BIPOLAR FORCEPS, 2-PIN CONNECTOR, YASARGIL BAYONET W/IRRIGATION, 6 1/4" (16CM) INSULATED, STRAIGHT TIP, (*SPECIFY TIP SIZE, A - 2.0 MM, B - 1.5 MM, C - 1.0 MM, D - 0.5 MM, E - NEEDLE)

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : BWA

Prescription Use : Yes

Device Count : 1

ELMED - 00842180100381 Catalog Number : 5550-07

Device Description : ELMED BIPOLAR FORCEPS, 2-PIN CONNECTOR, YASARGIL BAYONET W/IRRIGATION, 7 1/4" (1 ELMED BIPOLAR FORCEPS, 2-PIN CONNECTOR, YASARGIL BAYONET W/IRRIGATION, 7 1/4" (1821CM) INSULATED, STRAIGHT TIP, (*SPECIFY TIP SIZE, A - 2.0 MM, B - 1.5 MM, C - 1.0 MM, D - 0.5 MM, E - NEEDLE)

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : BWA

Prescription Use : Yes

Device Count : 1

ELMED - 00842180100398 Catalog Number : 5550-08

Device Description : ELMED BIPOLAR FORCEPS, 2-PIN CONNECTOR, YASARGIL BAYONET W/IRRIGATION, 8 1/4" (2 ELMED BIPOLAR FORCEPS, 2-PIN CONNECTOR, YASARGIL BAYONET W/IRRIGATION, 8 1/4" (21CM) INSULATED, STRAIGHT TIP, (*SPECIFY TIP SIZE, A - 2.0 MM, B - 1.5 MM, C - 1.0 MM, D - 0.5 MM, E - NEEDLE)

Device Class : 2

Duns Number: 049290364

Premarket Exempt : Yes

Product Code : BWA

Prescription Use : Yes

Device Count : 1

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