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) (5) Instrument, Ligature Passing And Knot Tying (HCF) (4) CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY (GEA) (1)

Premarket Exempt

No Yes

Clear

miniARM® - 00850012846154 Catalog Number : 080900

Device Description : SubX™ STERNAL ASCENDER™ SYSTEM

Device Class : 1

Duns Number: 603420183

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

miniARM® - 00850012846161 Catalog Number : 081214

Device Description : LIMA RetroSterno™ Paddle

Device Class : 1

Duns Number: 603420183

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

miniARM® - 00850012846178 Catalog Number : 081241

Device Description : RIMA RetroSterno™ Paddle

Device Class : 1

Duns Number: 603420183

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

miniARM® - 00850012846185 Catalog Number : 081202

Device Description : RetroSterno™ Paddle Kit (1 each LIMA and RIMA Paddle)

Device Class : 1

Duns Number: 603420183

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

A-GLIDE™ - 00850012846192 Catalog Number : 081200

Device Description : 25 cm A-GLIDE™ OF-25 Axial Soft Tissue Retractor

Device Class : 1

Duns Number: 603420183

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

JNW URTRAC™ - 00850012846222 Catalog Number : 081300

Device Description : JNW URTRAC™ Instrument Guide

Device Class : 1

Duns Number: 603420183

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

COR-KNOT MINI® - 00850200006070 Catalog Number : 031300

Device Description : COR-KNOT MINI® DEVICE KITBase Package Type - KitEach sterile package kit contain COR-KNOT MINI® DEVICE KITBase Package Type - KitEach sterile package kit contains (2) single patient use COR-KNOT MINI® Devices only.Rotating shaft.

Device Class :

Duns Number: 603420183

Premarket Exempt : No

Product Code : HCF

Prescription Use : Yes

Device Count : 2

COR-KNOT MINI® - 00850200006087 Catalog Number :

Device Description : COR-KNOT MINI® COMBO KITBase Package Type - KitEach sterile package kit contains COR-KNOT MINI® COMBO KITBase Package Type - KitEach sterile package kit contains (2) single patient use COR-KNOT MINI® Devices and (12) COR-KNOT® QUICK LOADS®.

Device Class : 1

Duns Number: 603420183

Premarket Exempt : No

Product Code : HCF

Prescription Use : Yes

Device Count : 1

TK® Ti-KNOT® DEVICE - 00850200006094 Catalog Number : 030404

Device Description : TK® Ti-KNOT® DEVICEEach sterile package contains (1) single patient use disposab TK® Ti-KNOT® DEVICEEach sterile package contains (1) single patient use disposable TITANIUM KNOT® placement device. Base Package Type - Each

Device Class : 1

Duns Number: 603420183

Premarket Exempt : No

Product Code : HCF

Prescription Use : Yes

Device Count : 1

COR-KNOT® MIS - 00850200006100 Catalog Number : 030800

Device Description : COR-KNOT® MIS DEVICE KITBase Package Type - KitEach sterile package kit contains COR-KNOT® MIS DEVICE KITBase Package Type - KitEach sterile package kit contains (2) single patient use COR-KNOT® MIS Devices.

Device Class :

Duns Number: 603420183

Premarket Exempt : No

Product Code : HCF

Prescription Use : Yes

Device Count : 2

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