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) (5)

Premarket Exempt

No Yes

Clear

Endo-Carry-on Procedure Kit - 40677964033962 Catalog Number : 4006291

Device Description : Endo Carry-on Procedure Kit includes Bedside Cleaning Tray, 5-piece Olympus DCA Endo Carry-on Procedure Kit includes Bedside Cleaning Tray, 5-piece Olympus DCA Kit, Round Sponge, Cleanascope Liners, Underpad, Lubricating Jelly, Guaze 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 - 40677964034006 Catalog Number : 4006285

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, Gauze, Double-Header Channel Valve 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 - 40677964034020 Catalog Number : 4006286

Device Description : Endo Carry-on Procedure Kit includes Bedside Cleaning Tray, Trasport Pad, Round Endo Carry-on Procedure Kit includes Bedside Cleaning Tray, Trasport Pad, Round Sponge, Surgi Lube, Gauze, Suction Tubing, Gown, Syringe, Solidifier bottle 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 - 40677964034105 Catalog Number : 4006272

Device Description : Endo Carry-on Procedure Kit includes Basin, Enzymatic Sponge, Transport Pad, CHU Endo Carry-on Procedure Kit includes Basin, Enzymatic Sponge, Transport Pad, CHUX Pad, Lubricating Jelly, Gauze, Suction Tubing, 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 - 40677964034129 Catalog Number : 4006273

Device Description : Endo Carry-on Procedure Kit includes Basin, Cylindrical Sponge, Bedside Concentr Endo Carry-on Procedure Kit includes Basin, Cylindrical Sponge, Bedside Concentrate, BioGuard Air Water Cleaning Adapter, Transport Pad, Lube Tube, Gauze Pads, and Intercept Detergent.

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

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