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) (2) HOLDER, CAMERA, SURGICAL (FXR) (1) INSTRUMENT, MANUAL, SURGICAL, GENERAL USE (MDM) (1) Laparoscope, general & plastic surgery (GCJ) (1)

Premarket Exempt

No Yes

Clear

miniARM™ - 00850200006902 Catalog Number : 080555

Device Description : miniARM™ LOCKING COUPLER

Device Class : 1

Duns Number: 603420183

Premarket Exempt : Yes

Product Code : FXR

Prescription Use : Yes

Device Count : 1

miniARM™ - 00850200006919 Catalog Number : 080670

Device Description : miniARM™ ACCESS ADAPTER

Device Class : 1

Duns Number: 603420183

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

COR-KNOT MICRO™ - 00850200006933 Catalog Number : 032500

Device Description : COR-KNOT MICRO™ DEVICE Pre-Loaded with (1) titanium COR-KNOT MICRO™ FASTENER

Device Class : 2

Duns Number: 603420183

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

miniRUMEL™ DEVICE - 00850200006971 Catalog Number : 080990

Device Description : miniRUMEL™ DEVICE, 15cm

Device Class : 1

Duns Number: 603420183

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

miniRUMEL™ DEVICE - 00850200006988 Catalog Number : 080995

Device Description : miniRUMEL™ DEVICE, 25cm

Device Class : 1

Duns Number: 603420183

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

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