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Cook Zenith Spiral-Z AAA Iliac Leg with Z-Trak Introduction System - HSA Registration DE0009151

Access comprehensive regulatory information for Cook Zenith Spiral-Z AAA Iliac Leg with Z-Trak Introduction System in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0009151 and owned by Cook Medical Incorporated. The device was registered on May 04, 2012.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS D
DE0009151
Cook Zenith Spiral-Z AAA Iliac Leg with Z-Trak Introduction System
HSA Registration Number: DE0009151
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Product Description

The Zenith Spiral-Z AAA Iliac Leg with the Z-Trak Introduction System is indicated for use with the Zenith AAA Endovascular Graft family of products, including the Zenith Flex AAA Endovascular Graft, Zenith Renu Ancillary Graft, Zenith Fenestrated AAA Endovascular Graft, or Zenith Branch Iliac Endovascular Graft, during either a primary or a secondary procedure in patients who have adequate iliac/femoral access compatible with the required introduction systems.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
HSA Product Code
HSAMDD00107
HS Code
90219000
Registration Information
Registration Number
DE0009151
Registration Date
May 04, 2012
Retention Due Date
May 03, 2026
Product Owner
Short Name
Cook
Address
1025 Acuff Road,, P.O. Box 4195, Bloomington, IN 47402-4195, UNITED STATES
Registrant
Address
38 BEACH ROAD, SOUTH BEACH TOWER, #29-11, SINGAPORE 189767
Importer
Address
38 BEACH ROAD, SOUTH BEACH TOWER, #29-11, SINGAPORE 189767
Model Information
Model Name(s)
Zenith Spiral-Z AAA Iliac Leg Zenith Spiral-Z AAA Iliac Leg Zenith Spiral-Z AAA Iliac Leg Zenith Spiral-Z AAA Iliac Leg Zenith Spiral-Z AAA Iliac Leg Zenith Spiral-Z AAA Iliac Leg Zenith Spiral-Z AAA Iliac Leg Zenith Spiral-Z AAA Iliac Leg Zenith Spiral-Z AAA Iliac Leg Zenith Spiral-Z AAA Iliac Leg Zenith Spiral-Z AAA Iliac Leg Zenith Spiral-Z AAA Iliac Leg Zenith Spiral-Z AAA Iliac Leg Zenith Spiral-Z AAA Iliac Leg Zenith Spiral-Z AAA Iliac Leg Zenith Spiral-Z AAA Iliac Leg Zenith Spiral-Z AAA Iliac Leg Zenith Spiral-Z AAA Iliac Leg Zenith Spiral-Z AAA Iliac Leg Zenith Spiral-Z AAA Iliac Leg Zenith Spiral-Z AAA Iliac Leg Zenith Spiral-Z AAA Iliac Leg Zenith Spiral-Z AAA Iliac Leg Zenith Spiral-Z AAA Iliac Leg Zenith Spiral-Z AAA Iliac Leg Zenith Spiral-Z AAA Iliac Leg Zenith Spiral-Z AAA Iliac Leg Zenith Spiral-Z AAA Iliac Leg Zenith Spiral-Z AAA Iliac Leg Zenith Spiral-Z AAA Iliac Leg
Model Identifier(s)
ZSLE-11-107-ZT ZSLE-11-122-ZT ZSLE-11-39-ZT ZSLE-11-56-ZT ZSLE-11-74-ZT ZSLE-11-90-ZT ZSLE-13-107-ZT ZSLE-13-122-ZT ZSLE-13-39-ZT ZSLE-13-56-ZT ZSLE-13-74-ZT ZSLE-13-90-ZT ZSLE-16-39-ZT ZSLE-16-56-ZT ZSLE-16-74-ZT ZSLE-16-90-ZT ZSLE-20-39-ZT ZSLE-20-56-ZT ZSLE-20-74-ZT ZSLE-20-90-ZT ZSLE-24-39-ZT ZSLE-24-56-ZT ZSLE-24-74-ZT ZSLE-24-90-ZT ZSLE-9-107-ZT ZSLE-9-122-ZT ZSLE-9-39-ZT ZSLE-9-56-ZT ZSLE-9-74-ZT ZSLE-9-90-ZT