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, MANUAL, SURGICAL, GENERAL USE (MDM) (10)

Premarket Exempt

No Yes

Clear

Synergetics - 10841305101514 Catalog Number : 40.01-6

Device Description : Flexible Translimbal Iris Retractors

Device Class : 1

Duns Number: 021056726

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

Synergetics - 10841305101521 Catalog Number : 40.02-6

Device Description : Disposable Flexible Translimbal Iris Retractor

Device Class : 1

Duns Number: 021056726

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

Synergetics - 10841305101644 Catalog Number : 58.00.20

Device Description : 20ga MVR Blade

Device Class : 1

Duns Number: 021056726

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

Synergetics - 10841305101651 Catalog Number : 58.00.23

Device Description : 23ga Disposable Angled Blade

Device Class : 1

Duns Number: 021056726

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

Synergetics - 10841305101675 Catalog Number : 58.20

Device Description : ONE-STEP™ Sutureless Cannula System

Device Class : 1

Duns Number: 021056726

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

Synergetics - 10841305101682 Catalog Number : 58.2023-3MM

Device Description : 20/23ga Infusing Instrument Cannula System

Device Class : 1

Duns Number: 021056726

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

Synergetics - 10841305101699 Catalog Number : 58.20-6

Device Description : ONE-STEP™ Sutureless Cannula

Device Class : 1

Duns Number: 021056726

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

Synergetics - 10841305101705 Catalog Number : 58.20V

Device Description : ONE-STEP™ Sutureless Cannula System with Valves

Device Class : 1

Duns Number: 021056726

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

Synergetics - 10841305101712 Catalog Number : 58.23

Device Description : 23ga ONE-STEP™ Sutureless Cannula System

Device Class : 1

Duns Number: 021056726

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

Synergetics - 10841305101743 Catalog Number : 58.23S

Device Description : 23ga ONE-STEP™ Cannula System - Stainless

Device Class : 1

Duns Number: 021056726

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

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