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CDSCO UID IMP/MD/2019/000114_ef7ffb75836dee0513185daaf9d9a058_c1153c7f0dfd03678933645ddd77d4af

Guide Sheath Introducers

M/s Merit Medical Systems India Private Limited,·Device Class Class C·India CDSCO·Brand: Prelude Roadster TM
Registration details
UID
IMP/MD/2019/000114_ef7ffb75836dee0513185daaf9d9a058_c1153c7f0dfd03678933645ddd77d4af
Device class
Class C
Brand name
Prelude Roadster TM
License holder
M/s Merit Medical Systems India Private Limited,
Approving authority
CDSCO
Product information
The Prelude Roadster Guide Sheath Introducer is indicated to be used for the introduction of interventional and diagnostic devices into the peripheral (Prelude Roadster TM) vasculature.
Other products from M/s Merit Medical Systems India Private Limited,
Products from the same license holder (7 products)
Hemostasis Valves and Accessories(Hemostasis Valves andAccessories )
Brand: Inflation devices either with Stopcocks / Hemostasis valves or with both
Class C
Angiographic Catheter
Brand: Inflation devices either with Stopcocks / Hemostasis valves or with both
Class C
Angiographic catheter
Brand: Inflation devices either with Stopcocks / Hemostasis valves or with both
Class C
Splittable Sheath Introducers
Brand: Inflation devices either with Stopcocks / Hemostasis valves or with both
Class C
Inflation Devices and Kits(BasixCOMPAK, BIG60 )
Brand: Inflation devices either with Stopcocks / Hemostasis valves or with both
Class C
Hydrophilic Guide Wire
Brand: EN Snare Endovascular Snare System
Class D
Diagnostic Guide Wire
Brand: EN Snare Endovascular Snare System
Class D
About this record

Guide Sheath Introducers is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000114_ef7ffb75836dee0513185daaf9d9a058_c1153c7f0dfd03678933645ddd77d4af. This device is marketed under the brand name Prelude Roadster TM. The license holder is M/s Merit Medical Systems India Private Limited,, and it is classified as Device Class Class C. The approving authority is CDSCO.

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