ZIEN MEDICAL TECHNOLOGIES, INC.

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

Catheter, Percutaneous, Cutting/Scoring (PNO) (2) Syringe, Piston (FMF) (1)

Premarket Exempt

No Yes

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PowrSyringe - B090PWR100 Catalog Number :

Device Description : The PowrSyringe is a disposable, hand-held, 10mL injection syringe that incorpor The PowrSyringe is a disposable, hand-held, 10mL injection syringe that incorporates ergonomic and mechanical advantages for fluid injection in a variety of medical procedures.

Device Class :

Duns Number: 017535668

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

XO Score - B090S6250650 Catalog Number : S6.25-065

Device Description : The XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is intended The XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring surface to the stenotic material in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries; and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

Device Class :

Duns Number: 017535668

Premarket Exempt : No

Product Code : PNO

Prescription Use : Yes

Device Count : 1

XO Score - B090S6500650 Catalog Number : S6.50-065

Device Class :

Duns Number: 017535668

Premarket Exempt : No

Product Code : PNO

Prescription Use : Yes

Device Count : 1

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