MEDIVATORS INC.

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

Endoscope introducer kit (NWU) (9) Accessories, Cleaning Brushes, For Endoscope (MNL) (1)

Premarket Exempt

No Yes

Clear

Custom Procedure Kit - 40677964027473 Catalog Number : 4005625

Device Description : Custom Procedure Kit includes Bedside Cleaning Tray, Intercept Detergent, Sponge Custom Procedure Kit includes Bedside Cleaning Tray, Intercept Detergent, Sponge, Lubricant, Transport Pad, Under Pad, Gauze Pad, Suction Tube, Gown, and Biohazard Sticker.

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

Custom Procedure Kit - 40677964027510 Catalog Number :

Device Class : 1

Duns Number: 068199363

Premarket Exempt : No

Product Code : MNL

Prescription Use : Yes

Device Count : 1

Custom Procedure Kit - 40677964027534 Catalog Number : 4005102

Device Description : Custom Procedure Kit includes Bedside Cleaning Tray, Intercept Detergent, Sponge Custom Procedure Kit includes Bedside Cleaning Tray, Intercept Detergent, Sponge, 5-piece Olympus DCA Kit, Transport Pad, Gauze Pad, Lubricating Jelly, Suction Tube, and Biohazard Sticker

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

Custom Procedure Kit - 40677964027558 Catalog Number : 4005103

Device Description : Custom Procedure Kit includes Bedside Cleaning Tray, Intercept Detergent, Sponge Custom Procedure Kit includes Bedside Cleaning Tray, Intercept Detergent, Sponge, 5-piece Olympus DCA Kit, Transport Pad, Gauze Pad, Lubricating Jelly, Suction Tube, and Biohazard Sticker

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

Custom Procedure Kit - 40677964027572 Catalog Number : 4005109

Device Description : Custom Procedure Kit includes Bedside Cleaning Tray, Round Sponge, 5-piece Olymp Custom Procedure Kit includes Bedside Cleaning Tray, Round Sponge, 5-piece Olympus DCA Kit, Transport Pad, Lubricating Jelly, Gauze Pad and Biohazard Sticker

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

Custom Procedure Kit - 40677964027619 Catalog Number : 4005410

Device Description : Custom Procedure Kit includes Bedside Cleaning Tray, 5-piece Olympus DCA Kit, L Custom Procedure Kit includes Bedside Cleaning Tray, 5-piece Olympus DCA Kit, Lubricant, Transport Pad and Gauze Pads

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

Custom Procedure Kit - 40677964027633 Catalog Number : 4005411

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

Custom Procedure Kit - 40677964027657 Catalog Number : 4005476

Device Description : Custom Procedure Kit includes Bedside Cleaning Tray, Intercept Detergent, Sponge Custom Procedure Kit includes Bedside Cleaning Tray, Intercept Detergent, Sponge, DEFENDO Biopsy Valve, Olympus and Fujifilm, Lubricating Jelly, Transport Pad, Gauze pad, Suction tube, Gown, Slip no- sterile Syringe, Back Flow Valve and Biohazard Sticker

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

Custom Procedure Kit - 40677964027671 Catalog Number : 4005475

Device Description : Custom Procedure Kit includes Bedside Cleaning Tray, Intercept Detergent, Sponge Custom Procedure Kit includes Bedside Cleaning Tray, Intercept Detergent, Sponge, Lubricating Jelly, Transport Pad, Gauze Pad, Suction Tube, Gown, Slip no- sterile Syringe, and Biohazard Sticker

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

Custom Procedure Kit - 40677964027862 Catalog Number : 4005608

Device Description : Custom Procedure Kit includes Basin, Sponge, Air Water Cleaning Adapter, Transpo Custom Procedure Kit includes Basin, Sponge, Air Water Cleaning Adapter, Transport Pad, Lubricating Jelly, Gauze, 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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