ZUTRON MEDICAL, L.L.C.

Address:17501 w 98th street,Lenexa,KS,66219,US

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- Catalog Number : ZUTR40001A

Device Description : CONTENTS:Endoscopy Kit- Lube Jelly (2)- Gauze (10)- Suction Tubing (10')- Cleani CONTENTS:Endoscopy Kit- Lube Jelly (2)- Gauze (10)- Suction Tubing (10')- Cleaning Brush- Tote500ml BasinBiopsy Port CoverBiohazard StickerConcentrated Z-SpongeEndoscope Tip ProtectorValve Storage Bag

Device Class :

Duns Number: 962532441

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

- Catalog Number : ZUTR141700

Device Description : When added scope siffness is desired to negotiate a difficult colon, and prior t When added scope siffness is desired to negotiate a difficult colon, and prior to repositioning the patient, simply insert the Colonoscope Stiffening Device into the biopsy port to stiffen the insertion tube and advance to the cecum. The device is then withdrawn and the procedure is completed as usual.These reusable devices are compatible with Pentax ®, Fujinon®, Olympus® and Fuse® non-variable stiffness endoscopes.

Device Class : 2

Duns Number: 962532441

Premarket Exempt : No

Product Code : FDF

Prescription Use : No

Device Count : 1

- Catalog Number : ZUTR161700

Device Description : When added scope siffness is desired to negotiate a difficult colon, and prior t When added scope siffness is desired to negotiate a difficult colon, and prior to repositioning the patient, simply insert the Colonoscope Stiffening Device into the biopsy port to stiffen the insertion tube and advance to the cecum. The device is then withdrawn and the procedure is completed as usual.These reusable devices are compatible with Pentax ®, Fujinon®, Olympus® and Fuse® non-variable stiffness endoscopes.

Device Class : 2

Duns Number: 962532441

Premarket Exempt : No

Product Code : FDF

Prescription Use : No

Device Count : 1

- Catalog Number : ZUTR162000

Device Description : The patented Endoscope Stiffening System (ESS) consists of the Colonoscope Stiff The patented Endoscope Stiffening System (ESS) consists of the Colonoscope Stiffening Device and Enteroscope StiffeningDevice.These are reusable devices that provide a simple way to temporarily stiffen the insertion tube of an endoscope during a procedure when difficult anatomy presents itself. They are compatible with Pentax ®, Fujinon®, and Olympus® non-variable stiffness endoscopes.

Device Class : 2

Duns Number: 962532441

Premarket Exempt : No

Product Code : FDF

Prescription Use : No

Device Count : 1

- Catalog Number : FSA-7501

Device Description : When added scope stiffness is desired to negotiate a difficult colon, and prior When added scope stiffness is desired to negotiate a difficult colon, and prior to re positioning the patient, simply insert the Colonoscope Stiffening Device into the biopsy port to stiffen the insertion tube and advance to the cecum. The device is then withdrawn and the procedure is completed as usual.These reusable devices are compatible with Pentax ®, Fujinon®, Olympus® and Fuse® non-variable stiffness endoscopes.

Device Class : 2

Duns Number: 962532441

Premarket Exempt : No

Product Code : FDF

Prescription Use : No

Device Count : 1