LSI Solutions, Inc.

LSI Solutions, Inc.

Address:7796 VICTOR-MENDON RD.,VICTOR,NY,14564,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) (6) INSTRUMENTS, SURGICAL, CARDIOVASCULAR (DWS) (4)

Premarket Exempt

No Yes

Clear

VALVEVAULT™ - 00850012846055 Catalog Number : 081025

Device Description : VALVEVAULT™ DEVICE (S) 19mm / 21mm

Device Class : 1

Duns Number: 603420183

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

VALVEVAULT™ - 00850012846062 Catalog Number : 081030

Device Description : VALVEVAULT™ DEVICE (M) 23mm / 25mm

Device Class : 1

Duns Number: 603420183

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

VALVEVAULT™ - 00850012846079 Catalog Number : 081035

Device Description : VALVEVAULT™ DEVICE (L) 27mm / 29mm

Device Class : 1

Duns Number: 603420183

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

VALVEVAULT™ - 00850012846086 Catalog Number : 081040

Device Description : VALVEVAULT™ DEVICE KITThis kit includes one (1) each non-sterile, reusable VALVE VALVEVAULT™ DEVICE KITThis kit includes one (1) each non-sterile, reusable VALVEVAULT™ DEVICE (S), (M), (L), all of which have Direct Marking.

Device Class : 1

Duns Number: 603420183

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

miniARM® - 00850012846093 Catalog Number : 081010

Device Description : M45™ CLICK RELEASE™ miniARM® Holder

Device Class : 1

Duns Number: 603420183

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

miniARM® - 00850012846109 Catalog Number : 081000

Device Description : miniARM® triDOC™ Rail Clamp

Device Class : 1

Duns Number: 603420183

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

miniARM® - 00850012846116 Catalog Number : 081022

Device Description : miniARM® monoDOC™ Rail Clamp

Device Class : 1

Duns Number: 603420183

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

miniARM® - 00850012846123 Catalog Number : 081023

Device Description : miniARM® duoDOC™ Left Rail Clamp

Device Class : 1

Duns Number: 603420183

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

miniARM® - 00850012846130 Catalog Number : 081024

Device Description : miniARM® duoDOC™ Right Rail Clamp

Device Class : 1

Duns Number: 603420183

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

miniARM® - 00850012846147 Catalog Number : 080950

Device Description : M55™ RIGID miniARM® HOLDER

Device Class : 1

Duns Number: 603420183

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

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