MEDIVATORS INC.

Address:14605 28th Ave North,MINNEAPOLIS,MN,55447,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 - 40677964033320 Catalog Number : 4006201

Device Description : Endo Carry-on Procedure Kit includes Bedside Cleaning Tray, Enzymatic Sponge, 5- Endo Carry-on Procedure Kit includes Bedside Cleaning Tray, Enzymatic Sponge, 5-piece Olympus DCA Kit, Transport Pad, Lubricating Jelly, Gauze Pads, Double-header Channel Brush, Syringe 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 - 40677964033344 Catalog Number : 4006202

Device Description : Endo Carry-on Procedure Kit includes Bedside Cleaning Tray Intercept Detergent, Endo Carry-on Procedure Kit includes Bedside Cleaning Tray Intercept Detergent, Flat Sponge, 5-piece Olympus DCA Kit, Transport Pad, Lubricating Jelly, 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 - 40677964033368 Catalog Number : 4006203

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, Biohazard Sticker and Doubler-Header Channel Valve Brush.

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

Endo-Carry-on Procedure Kit - 40677964033405 Catalog Number : 4006135

Device Description : Endo Carry-on Procedure Kit includes Bedside Cleaning Tray, Intercept Detergent, Endo Carry-on Procedure Kit includes Bedside Cleaning Tray, Intercept Detergent, Compressed Sponge, 5-piece Olympus DCA Kit, Transport Pad, CHUX Pad, Lubricating Jelly, and Gauze.

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

Endo-Carry-on Procedure Kit - 40677964033504 Catalog Number : 4006230

Device Description : Endo Carry-on Procedure Kit includes Lube Tube, Suction Tube, and Defendo Valve Endo Carry-on Procedure Kit includes Lube Tube, Suction Tube, and Defendo Valve Kit (4-piece).

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

Endo-Carry-on Procedure Kit - 40677964033528 Catalog Number : 4006231

Device Description : Endo Carry-on Procedure Kit includes Bedside Cleaning Tray,Intercept Detergent, Endo Carry-on Procedure Kit includes Bedside Cleaning Tray,Intercept Detergent, Flat Sponge, Transport Pad, Lube Tube, 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 - 40677964033627 Catalog Number : 4006222

Device Description : Endo Carry-on Procedure Kit includes Basin, Intercept Detergent, Flat Sponge, an Endo Carry-on Procedure Kit includes Basin, Intercept Detergent, Flat Sponge, and Lubricating Jelly.

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

Endo-Carry-on Procedure Kit - 40677964033641 Catalog Number : 4006223

Device Description : Endo Carry-on Procedure Kit includes Basin, Round Sponge, Transport Pad, Lube Tu Endo Carry-on Procedure Kit includes Basin, Round Sponge, Transport Pad, Lube Tube, Gown, Biohazard Sticker, and Gauze.

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

Endo-Carry-on Procedure Kit - 40677964033665 Catalog Number : 4006224

Device Description : Endo Carry-on Procedure Kit includes Basin, Enzymatic Sponge, Transport Pad, Lub Endo Carry-on Procedure Kit includes Basin, Enzymatic Sponge, Transport Pad, Lubricating Jelly and Guaze.

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

Endo-Carry-on Procedure Kit - 40677964033702 Catalog Number : 4006240

Device Description : Endo Carry-on Procedure Kit includes Bedside Cleaning Tray, Intercept Detergent, Endo Carry-on Procedure Kit includes Bedside Cleaning Tray, Intercept Detergent, Flat Sponge, BioGuard Air Water Cleaning Adapter, Transport Pad, Lube Tube, Gauze Pads, and Suction Tubing.

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

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