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Cook SteadySheath® Evolution® Shortie Tissue Stabilization Sheath - HSA Registration DE0508413

Access comprehensive regulatory information for Cook SteadySheath® Evolution® Shortie Tissue Stabilization Sheath in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0508413 and owned by Cook Vandergrift Inc. The device was registered on August 18, 2023.

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
DE0508413
Cook SteadySheath® Evolution® Shortie Tissue Stabilization Sheath
HSA Registration Number: DE0508413
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Product Description

The Cook SteadySheath® Evolution® Shortie Tissue Stabilization Sheath is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0508413
Registration Date
August 18, 2023
Retention Due Date
August 17, 2025
Product Owner
Short Name
Cook Vandergrift Inc
Address
1186 Montgomery Lane, Vandergrift, Pennsylvania 15690, 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)
SteadySheath® Shortie 11 Fr Evolution® Tissue Stabilization Sheath SteadySheath® Shortie 9 Fr Evolution® Tissue Stabilization Sheath
Model Identifier(s)
LR-TSS-SH-11.0 LR-TSS-SH-9.0