SYNERGETICS USA, INC.

Address:3845 Corporate Centre Dr,O Fallon,MO,63368,US

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Filters

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) (5) Endoilluminator (MPA) (4) Apparatus, cautery, radiofrequency, ac-powered (HQR) (1)

Premarket Exempt

No Yes

Clear

Synergetics - 20841305110834 Catalog Number : DSYN-LB90-05I

Device Description : "The Lumenator™" Spetzler™-Malis® Disposable Lighted Bipolar Forceps, Bayonet, 9 "The Lumenator™" Spetzler™-Malis® Disposable Lighted Bipolar Forceps, Bayonet, 9", .5mm Tip, Insulated, Non-Stick

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 5

Synergetics - 20841305110858 Catalog Number : DSYN-LB90-10I

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 5

Synergetics - 20841305110872 Catalog Number : DSYN-LB90-15I

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 5

Synergetics - 20841305111053 Catalog Number : 53.00.27

Device Description : 27ga Bipolar Cautery

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : HQR

Prescription Use : Yes

Device Count : 6

Synergetics - 20841305111138 Catalog Number : BL5820M

Device Description : 20ga Stellaris PC Mid-Field Endoilluminator

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : MPA

Prescription Use : Yes

Device Count : 12

Synergetics - 20841305111152 Catalog Number : BL5820D

Device Description : 20ga Stellaris PC Diffuse Wide-Field Endoilluminator

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : MPA

Prescription Use : Yes

Device Count : 12

Synergetics - 20841305111831 Catalog Number : BL5820D

Device Description : 20ga Stellaris PC Diffuse Wide-Field Endoilluminator

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : MPA

Prescription Use : Yes

Device Count : 12

Synergetics - 20841305111855 Catalog Number : BL5820M

Device Description : 20ga Stellaris PC Mid-Field Endoilluminator

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : MPA

Prescription Use : Yes

Device Count : 12

Codman - 20886704065446 Catalog Number : 80-1270

Device Description : Disposable Spetzler™-Malis® Standard Bipolar Forceps, Bayonet, 7" (18cm), 1.0mm Disposable Spetzler™-Malis® Standard Bipolar Forceps, Bayonet, 7" (18cm), 1.0mm Tip, Insulated, Non-Stick

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 5

Codman - 20886704065453 Catalog Number : 80-1271

Device Description : Disposable Spetzler™-Malis® Standard Bipolar Forceps, Bayonet, 7" (18cm), 1.5mm Disposable Spetzler™-Malis® Standard Bipolar Forceps, Bayonet, 7" (18cm), 1.5mm Tip, Insulated, Non-Stick

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 5

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