MEDIVATORS INC.

Address:3150 Pollok Drive,Conroe,TX,77303,US

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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

Endoscope introducer kit (NWU) (10)

Premarket Exempt

No Yes

Clear

Endo-Carry-on Procedure Kit - 40677964033122 Catalog Number : 4006146

Device Description : Endo Carry-on Procedure Kit includes Intercept Bedside Kit, Sponge, 5-piece Olym Endo Carry-on Procedure Kit includes Intercept Bedside Kit, Sponge, 5-piece Olympus DCA Kit, Transport Pad, Lubricating Jelly, Gauze Pads, and Biohazard Sticker.

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

Endo-Carry-on Procedure Kit - 40677964033146 Catalog Number : 4006147

Device Description : Endo Carry-on Procedure Kit includes Intercept Bedside Kit, Flat Sponge, Cleanin Endo Carry-on Procedure Kit includes Intercept Bedside Kit, Flat Sponge, Cleaning Adapter, Transport Pad, and Gauze Pads.

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

Endo-Carry-on Procedure Kit - 40677964033160 Catalog Number : 4006148

Device Description : Endo Carry-on Procedure Kit includes Basin, Enzymatic Sponge, 5-piece Olympus DC Endo Carry-on Procedure Kit includes Basin, Enzymatic Sponge, 5-piece Olympus DCA Kit, Transport Pad, Lubricating Jelly, Suction Tube, Gauze, Double-Header Channel Brush, Gown, and Biohazard Sticker.

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

Endo-Carry-on Procedure Kit - 40677964033184 Catalog Number : 4006181

Device Description : Endo Carry-on Procedure Kit includes Intercept Bedside Kit, Sponge, Defendo Biop Endo Carry-on Procedure Kit includes Intercept Bedside Kit, Sponge, Defendo Biopsy Valve, Transport Pad, Lubricating Jelly, Gauze Pads, Suction Tube, Gown, and Water Jet Connector.

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

Endo-Carry-on Procedure Kit - 40677964033207 Catalog Number : 4006155

Device Description : Endo Carry-on Procedure Kit includes Bedside Cleaning Tray, Enzymatic Sponge, Bi Endo Carry-on Procedure Kit includes Bedside Cleaning Tray, Enzymatic Sponge, Bioshield, Transport Pad, Lubricant, Gauze Pads, Stubby Brush, Cleaning Brush, and Biohazard Sticker.

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

Endo-Carry-on Procedure Kit - 40677964033221 Catalog Number : 4006157

Device Description : Endo Carry-on Procedure Kit includes Basin, Enzymatic Sponge, 5-piece Olympus DC Endo Carry-on Procedure Kit includes Basin, Enzymatic Sponge, 5-piece Olympus DCA Kit, Transport Pad, Lubricant, Gauze, Double-header Channel Brush, and Biohazard Sticker.

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

Endo-Carry-on Procedure Kit - 40677964033245 Catalog Number : 4006190

Device Description : Endo Carry-on Procedure Kit includes Basin, Enzymatic Sponge, 5-piece Olympus DC Endo Carry-on Procedure Kit includes Basin, Enzymatic Sponge, 5-piece Olympus DCA Kit, Chux Pad, Lubricant, Suction Tube, Gauze, and Bio Hazard Sticker.

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

Endo-Carry-on Procedure Kit - 40677964033269 Catalog Number : 4006191

Device Description : Endo Carry-on Procedure Kit includes Basin, Enzymatic Sponge, Defendo Valves Kit Endo Carry-on Procedure Kit includes Basin, Enzymatic Sponge, Defendo Valves Kit, Transport Pad, Lubricating Jelly, Gauze, Brush and Bio Hazard Sticker.

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

Endo Carry-on Procedure Kit - 40677964033283 Catalog Number : 4006192

Device Description : Endo Carry-on Procedure Kit includes Bedside Cleaning Tray, Intercept Detergent, Endo Carry-on Procedure Kit includes Bedside Cleaning Tray, Intercept Detergent, Cylindrical Sponge, 5-Piece Olympus DCA Kit, Transport Pad, Lubricating Jelly, Gauze Pads and Suction Tube.

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

Endo-Carry-on Procedure Kit - 40677964033306 Catalog Number : 4006200

Device Description : Endo Carry-on Procedure Kit includes Basin, Enzymatic Sponge, Transport Pad, Lu Endo Carry-on Procedure Kit includes Basin, Enzymatic Sponge, Transport Pad, Lubricating Jelly, Gauze and Doubler Ended Header Channel Valve Brush.

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

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