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

Transilluminator, ac-powered (HJM) (6) INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED (HQE) (3) Tubing, Replacement, Phacofragmentation Unit (MSR) (1)

Premarket Exempt

No Yes

Clear

Synergetics - 20841305109715 Catalog Number : 70027SP

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

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : HQE

Prescription Use : Yes

Device Count : 6

AGPI - 20841305109944 Catalog Number : 17565-10

Device Description : Adjustable Gas Pressured Infusion Tubing Set

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : MSR

Prescription Use : Yes

Device Count : 10

Synergetics - 20841305109968 Catalog Number : BL5623S

Device Description : 23ga Stellaris PC Vitrectomy Probe

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : HQE

Prescription Use : Yes

Device Count : 6

Synergetics - 20841305109982 Catalog Number : BL5625S

Device Description : 25ga Stellaris PC Vitrectomy Probe

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : HQE

Prescription Use : Yes

Device Count : 6

Synergetics - 20841305110094 Catalog Number : BL5823M

Device Description : 23ga Stellaris PC Midfield Endoilluminator

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : HJM

Prescription Use : Yes

Device Count : 12

Synergetics - 20841305110117 Catalog Number : BL5825M

Device Description : 25ga Stellaris PC Midfield Endoilluminator

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : HJM

Prescription Use : Yes

Device Count : 12

Synergetics - 20841305110131 Catalog Number : BL5827M

Device Description : 27ga Stellaris PC Midfield Endoilluminator

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : HJM

Prescription Use : Yes

Device Count : 12

Synergetics - 20841305110155 Catalog Number : BL5823D

Device Description : 23ga Stellaris PC Diffuse Wide Field Endoilluminator

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : HJM

Prescription Use : Yes

Device Count : 12

Synergetics - 20841305110179 Catalog Number : BL5825D

Device Description : 25ga Stellaris PC Diffuse Wide Field Endoilluminator

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : HJM

Prescription Use : Yes

Device Count : 12

Synergetics - 20841305110193 Catalog Number : BL5235S

Device Description : 25ga Vivid Chandelier - Stellaris PC

Device Class :

Duns Number: 021056726

Premarket Exempt : No

Product Code : HJM

Prescription Use : Yes

Device Count : 12

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