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) (8) Photocoagulator and accessories (HQB) (1) Transilluminator, ac-powered (HJM) (1)

Premarket Exempt

No Yes

Clear

Synergetics - 20841305110216 Catalog Number : BL5237S

Device Description : 27ga Vivid Chandelier - Stellaris PC

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : HJM

Prescription Use : Yes

Device Count : 12

Synergetics - 20841305110254 Catalog Number : 70020E

Device Description : 20ga VersaVIT 2.0™ Core Essentials Procedure Pack

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : HQE

Prescription Use : Yes

Device Count : 6

Synergetics - 20841305110278 Catalog Number : 70027E

Device Description : 27ga VersaVIT 2.0™ Core Essentials Procedure Pack

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : HQE

Prescription Use : Yes

Device Count : 6

Synergetics - 20841305110292 Catalog Number : 70020S

Device Description : 20ga VersaVIT 2.0™ Procedure Pack with Mid-Field Illuminator

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : HQE

Prescription Use : Yes

Device Count : 6

Synergetics - 20841305110315 Catalog Number : 70027S

Device Description : 27ga VersaVIT 2.0™ Procedure Pack with Mid-Field Illuminator

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : HQE

Prescription Use : Yes

Device Count : 6

Synergetics - 20841305110339 Catalog Number : 70020SP

Device Description : 20ga VersaVIT 2.0™ Procedure Pack with PHOTON™ Wide Field Illuminator

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : HQE

Prescription Use : Yes

Device Count : 6

Synergetics - 20841305110353 Catalog Number : 70123B

Device Description : 23ga VersaVIT 2.0™ Core Essentials Biopsy Procedure Pack

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : HQE

Prescription Use : Yes

Device Count : 6

Synergetics - 20841305110377 Catalog Number : 70125B

Device Description : 25ga VersaVIT 2.0™ Core Essentials Biopsy Procedure Pack

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : HQE

Prescription Use : Yes

Device Count : 6

Synergetics - 20841305110391 Catalog Number : 70127B

Device Description : 27ga VersaVIT 2.0™ Core Essentials Biopsy Procedure Pack

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : HQE

Prescription Use : Yes

Device Count : 6

Synergetics - 20841305110414 Catalog Number : 55.62.25PX

Device Description : 25ga Straight Fixed Extended Illuminated Laser Probe

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : HQB

Prescription Use : Yes

Device Count : 12

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