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 - 10841305101750 Catalog Number : 58.23STH

Device Description : 23ga Stealth Port Entry System

Device Class : 1

Duns Number: 021056726

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

Synergetics - 10841305101767 Catalog Number : 58.23STHV

Device Description : 23ga Valved Stealth Port Entry System

Device Class : 1

Duns Number: 021056726

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

Synergetics - 10841305101774 Catalog Number : 58.23SV

Device Description : 23ga Valved ONE-STEP™ Port Entry System

Device Class : 1

Duns Number: 021056726

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

Synergetics - 10841305101798 Catalog Number : 58.25

Device Description : 25ga ONE-STEP™ Sutureless Cannula System

Device Class : 1

Duns Number: 021056726

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

Synergetics - 10841305101804 Catalog Number : 58.25S

Device Description : 25ga ONE-STEP™ Cannula System - Stainless

Device Class : 1

Duns Number: 021056726

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

Synergetics - 10841305101811 Catalog Number : 58.25STH

Device Description : 25ga Stealth Port Entry System

Device Class : 1

Duns Number: 021056726

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

Synergetics - 10841305101828 Catalog Number : 58.25STHV

Device Description : 25ga Valved Stealth Port Entry System

Device Class : 1

Duns Number: 021056726

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

Synergetics - 10841305101835 Catalog Number : 58.25SV

Device Description : 25ga Valved ONE-STEP™ Port Entry System

Device Class : 1

Duns Number: 021056726

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

Synergetics - 10841305101842 Catalog Number : 58.27S

Device Description : 27ga Port Entry System - Stainless

Device Class : 1

Duns Number: 021056726

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

Synergetics - 10841305101859 Catalog Number : 58.27SV

Device Description : 27ga Valved Port Entry System

Device Class : 1

Duns Number: 021056726

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

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