LEXION MEDICAL, LLC

Address:545 Atwater Cir,Saint Paul,MN,55103,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

Insufflator, Laparoscopic (HIF) (10) Laparoscope, General & Plastic Surgery (GCJ) (10) Insufflator, Endoscopic Vessel Harvesting (OSV) (5)

Premarket Exempt

No Yes

Clear

INSUFLOW SYNERGY XL PORT - 00852588007106 Catalog Number : 1991-10

Device Description : 10mm GAS CONDITIONING PORT

Device Class : 2

Duns Number: 848693730

Premarket Exempt : No

Product Code : HIF, GCJ

Prescription Use : Yes

Device Count : 1

INSUFLOW SYNERGY XL PORT - 00852588007113 Catalog Number : 1991-12

Device Description : 12mm GAS CONDITIONING PORT

Device Class : 2

Duns Number: 848693730

Premarket Exempt : No

Product Code : GCJ, HIF

Prescription Use : Yes

Device Count : 1

INSUFLOW SYNERGY XL PORT - 00852588007120 Catalog Number : 1991-8B

Device Description : 8mm X 130mm GAS CONDITIONING PORT

Device Class : 2

Duns Number: 848693730

Premarket Exempt : No

Product Code : GCJ, HIF

Prescription Use : Yes

Device Count : 1

iNSUFLOW SYNERGY XL PORT - 00852588007137 Catalog Number : 1991-10B

Device Description : 10mm X 130mm GAS CONDITIONING PORT

Device Class : 2

Duns Number: 848693730

Premarket Exempt : No

Product Code : GCJ, HIF

Prescription Use : Yes

Device Count : 1

INSUFLOW SYNERGY XL PORT - 00852588007144 Catalog Number : 1991-12B

Device Description : 12mm X 130mm GAS CONDITIONING PORT

Device Class : 2

Duns Number: 848693730

Premarket Exempt : No

Product Code : GCJ, HIF

Prescription Use : Yes

Device Count : 1

Insuflow Port - 00852588007151 Catalog Number : 4100-5

Device Description : 5mm x 100mm Insuflow Port

Device Class : 2

Duns Number: 848693730

Premarket Exempt : No

Product Code : HIF, GCJ, OSV

Prescription Use : Yes

Device Count : 1

Insuflow Port - 00852588007168 Catalog Number : 4100-8

Device Description : 8mm x 100mm Insuflow Port

Device Class : 2

Duns Number: 848693730

Premarket Exempt : No

Product Code : HIF, GCJ, OSV

Prescription Use : Yes

Device Count : 1

Insuflow Port - 00852588007175 Catalog Number : 4100-8B

Device Description : 8mm x 130mm Insuflow Port

Device Class : 2

Duns Number: 848693730

Premarket Exempt : No

Product Code : HIF, GCJ, OSV

Prescription Use : Yes

Device Count : 1

Insuflow Port - 00852588007182 Catalog Number : 4100-10

Device Description : 10mm x 100mm Insuflow Port

Device Class : 2

Duns Number: 848693730

Premarket Exempt : No

Product Code : HIF, GCJ, OSV

Prescription Use : Yes

Device Count : 1

Insuflow Port - 00852588007199 Catalog Number : 4100-10B

Device Description : 10mm x 130mm Insuflow Port

Device Class : 2

Duns Number: 848693730

Premarket Exempt : No

Product Code : HIF, GCJ, OSV

Prescription Use : Yes

Device Count : 1

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