ZIEN MEDICAL TECHNOLOGIES, INC.

Address:2490 South 300 West,Salt Lake City,UT,84115,US

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- Catalog Number : PB-M-10

Device Description : The PenBlade Safety Scalpel is a scalpel which contains a mechanism to extend an The PenBlade Safety Scalpel is a scalpel which contains a mechanism to extend and retract a blade between an exposed and a retracted safe position.

Device Class :

Duns Number: 017535668

Premarket Exempt : Yes

Product Code : GDX

Prescription Use : No

Device Count : 10

- Catalog Number : PB-M-11P

Device Description : The PenBlade Safety Scalpel is a scalpel which contains a mechanism to extend an The PenBlade Safety Scalpel is a scalpel which contains a mechanism to extend and retract a blade between an exposed and a retracted safe position.

Device Class :

Duns Number: 017535668

Premarket Exempt : Yes

Product Code : GDX

Prescription Use : No

Device Count : 10

- Catalog Number : PB-M-15

Device Description : The PenBlade Safety Scalpel is a scalpel which contains a mechanism to extend an The PenBlade Safety Scalpel is a scalpel which contains a mechanism to extend and retract a blade between an exposed and a retracted safe position.

Device Class :

Duns Number: 017535668

Premarket Exempt : Yes

Product Code : GDX

Prescription Use : No

Device Count : 10

- Catalog Number : 30-ASP

Device Description : ASPIRE Mechanical Aspirators for aspiration of fluids from the body anywhere a s ASPIRE Mechanical Aspirators for aspiration of fluids from the body anywhere a syringe is used.

Device Class :

Duns Number: 017535668

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

- Catalog Number : 5X-GW

Device Description : Distal Access torque devices are used to maneuver guidewires in the coronary and Distal Access torque devices are used to maneuver guidewires in the coronary and peripheral vasculature during interventional or diagnostic procedures. Distal Access torque devices are not intended for use in the neurovasculature

Device Class :

Duns Number: 017535668

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

- Catalog Number : A11-060

Device Description : The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirato The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.

Device Class :

Duns Number: 017535668

Premarket Exempt : No

Product Code : QEZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : A11-090

Device Description : The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirato The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.

Device Class :

Duns Number: 017535668

Premarket Exempt : No

Product Code : QEZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : A5-055

Device Description : ASPIRE MAX 5 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli ASPIRE MAX 5 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.

Device Class : 2

Duns Number: 017535668

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

- Catalog Number : A5-135

Device Description : ASPIRE MAX 5 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli ASPIRE MAX 5 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.

Device Class : 2

Duns Number: 017535668

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1

- Catalog Number : A6-055

Device Description : ASPIRE MAX 6 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli ASPIRE MAX 6 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.

Device Class :

Duns Number: 017535668

Premarket Exempt : No

Product Code : DXE

Prescription Use : Yes

Device Count : 1