Vascular Closure Device - India CDSCO Medical Device Registration
Vascular Closure Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000230_d8a9f2c0acdaf9986be4febe664de503_24b9c7b963463edd3f0a0948e53eb3c4. This device is marketed under the brand name OPTEASE®. The license holder is Cardinal Health Medical Products India Pvt Ltd, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
OPTEASE®
License Holder
Cardinal Health Medical Products India Pvt LtdDevice Class
Approving Authority
CDSCO
Product Information
The EXOSEAL™ Vascular Closure Device is indicated for femoral artery puncture site closure, reducing time to hemostasis and ambulation in patients who have undergone diagnostic or interventional procedures using a standard corresponding French size vascular sheath introducer with up to a 12 cm working length
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