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

Instrument, vitreous aspiration and cutting, ac-powered (HQE) (3) INSTRUMENT, MICROSURGICAL (GZX) (2) INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED (HQE) (2) Photocoagulator and accessories (HQB) (2) Cannula, Ophthalmic (HMX) (1)

Premarket Exempt

No Yes

Clear

Synergetics - 20841305108527 Catalog Number : 70935

Device Description : 25ga VersaVIT 2.0™ Vitrectomy Probe

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : HQE

Prescription Use : Yes

Device Count : 6

Synergetics - 20841305108831 Catalog Number : 20.04.23

Device Description : 23ga Tano Diamond Dusted Membrane Scraper (DDMS™)

Device Class :

Duns Number: 021056726

Premarket Exempt : Yes

Product Code : GZX

Prescription Use : Yes

Device Count : 5

Synergetics - 20841305108848 Catalog Number : 20.04.25S

Device Description : Stiff 25ga Tano Diamond Dusted Membrane Scraper (DDMS™)

Device Class :

Duns Number: 021056726

Premarket Exempt : Yes

Product Code : GZX

Prescription Use : Yes

Device Count : 5

Synergetics - 20841305109401 Catalog Number : 31.01

Device Description : Replacement Backflush Reservoir

Device Class : 1

Duns Number: 021056726

Premarket Exempt : Yes

Product Code : HMX

Prescription Use : Yes

Device Count : 1

Synergetics - 20841305109487 Catalog Number : 55.48.23P

Device Description : 23ga Illuminated Directional II Laser Probe

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : HQB

Prescription Use : Yes

Device Count : 12

Synergetics - 20841305109494 Catalog Number : 55.48.25P

Device Description : 25ga Illuminated Directional II Laser Probe

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : HQB

Prescription Use : Yes

Device Count : 12

Synergetics - 20841305109555 Catalog Number : 65960

Device Description : 20ga VersaVIT™ Vitrectomy Probe, 6ft

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : HQE

Prescription Use : Yes

Device Count : 6

Synergetics - 20841305109562 Catalog Number : 65967

Device Description : 27ga VersaVIT™ Vitrectomy Probe, 6ft

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : HQE

Prescription Use : Yes

Device Count : 6

Synergetics - 20841305109593 Catalog Number : 70023SID

Device Description : 23ga VersaVIT 2.0™ Procedure Pack with Illuminated Directional Laser Probe

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : HQE

Prescription Use : Yes

Device Count : 6

Synergetics - 20841305109692 Catalog Number : 70025SID

Device Description : 25ga VersaVIT 2.0™ Procedure Pack with Illuminated Directional Laser Probe

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : HQE

Prescription Use : Yes

Device Count : 6

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