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

INSTRUMENTS, SURGICAL, CARDIOVASCULAR (DWS) (7) CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY (GEA) (1) INSTRUMENT, LIGATURE PASSING AND KNOT TYING (HCF) (1) INSTRUMENT, MANUAL, SURGICAL, GENERAL USE (MDM) (1)

Premarket Exempt

Yes No

Clear

AORTIC ROOT RETRACTOR - 00850200006575 Catalog Number : 080260

Device Description : AORTIC ROOT RETRACTOR, MEDIUM

Device Class : 1

Duns Number: 603420183

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

miniRUMEL™ - 00850200006582 Catalog Number : 080130

Device Description : miniRUMEL™ Device Each sterile pouch contains one (1) SINGLE PATIENT USE miniRUM miniRUMEL™ Device Each sterile pouch contains one (1) SINGLE PATIENT USE miniRUMEL™ Device.

Device Class : 1

Duns Number: 603420183

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

miniARM™ - 00850200006599 Catalog Number : 080415

Device Description : miniARM™ CANNULA ADAPTOR KIT

Device Class : 1

Duns Number: 603420183

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

miniARM™ - 00850200006605 Catalog Number : 080419

Device Description : miniARM™ INSTRUMENT HOLDER RIGHT

Device Class : 1

Duns Number: 603420183

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

C1® Device - 00850200006612 Catalog Number : 022600

Device Description : C1® SUTURING DEVICE (STRAIGHT SHAFT)

Device Class : 1

Duns Number: 603420183

Premarket Exempt : No

Product Code : HCF

Prescription Use : Yes

Device Count : 1

SEW-EASY® - 00850200006636 Catalog Number : 022797

Device Description : SEW-EASY® DEVICE 5.0 COMBO KIT

Device Class : 1

Duns Number: 603420183

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

SEW-EASY® - 00850200006643 Catalog Number : 022804

Device Description : SEW-EASY® DEVICE 5.0 KIT

Device Class : 1

Duns Number: 603420183

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

SEW-EASY® CASSETTE - 00850200006650 Catalog Number : 022811

Device Description : SEW-EASY® DEVICE 5.0 CASSETTE SINGLES

Device Class : 1

Duns Number: 603420183

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

RAM® - 00850200006667 Catalog Number : 022580

Device Description : RAM® SUTURING DEVICE 5mm

Device Class : 1

Duns Number: 603420183

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

RAM® DEVICE - 00850200006674 Catalog Number : 021900

Device Description : RAM® SUTURING DEVICE 3.5mm

Device Class : 1

Duns Number: 603420183

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

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