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) (3) Endoilluminator (MPA) (3) Instrument, vitreous aspiration and cutting, ac-powered (HQE) (3) Photocoagulator and accessories (HQB) (1)

Premarket Exempt

No Yes

Clear

Synergetics - 20841305110438 Catalog Number : 55.36.23ETX

Device Description : 23ga Inverted Extendable Directional Laser Probe

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : HQB

Prescription Use : Yes

Device Count : 12

Synergetics - 20841305110452 Catalog Number : 56.44P

Device Description : 20ga Irrigating Illuminated Capone Pick

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : MPA

Prescription Use : Yes

Device Count : 12

Synergetics - 20841305110476 Catalog Number : BL5823F

Device Description : 23ga Stellaris PC Focal Endoilluminator

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : MPA

Prescription Use : Yes

Device Count : 12

Synergetics - 20841305110490 Catalog Number : BL5825F

Device Description : 25ga Stellaris PC Focal Endoilluminator

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : MPA

Prescription Use : Yes

Device Count : 12

Synergetics - 20841305110575 Catalog Number : 65933

Device Description : 23ga VersaVIT™ Vitrectomy Probe, 3ft

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : HQE

Prescription Use : Yes

Device Count : 6

Synergetics - 20841305110599 Catalog Number : 65935

Device Description : 25ga VersaVIT™ Vitrectomy Probe, 3ft

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : HQE

Prescription Use : Yes

Device Count : 6

Synergetics - 20841305110612 Catalog Number : 70937

Device Description : 27ga VersaVIT 2.0™ Vitrectomy Probe

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : HQE

Prescription Use : Yes

Device Count : 6

Synergetics - 20841305110773 Catalog Number : DSYN-LB80-05I

Device Description : "The Lumenator™" Spetzler™-Malis® Disposable Lighted Bipolar Forceps, Bayonet, 8 "The Lumenator™" Spetzler™-Malis® Disposable Lighted Bipolar Forceps, Bayonet, 8", 0.5mm Tip, Insulated, Non-Stick

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 5

Synergetics - 20841305110797 Catalog Number : DSYN-LB80-10I

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 5

Synergetics - 20841305110810 Catalog Number : DSYN-LB80-15I

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 5

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