Saudi Arabia SFDA registration ME0000006512SFDAA00193
Fixed Core Bentson Curved
Saudi Arabia·Medical Device·COOK INCORPORATED·Class IIaActiveProduct information
Intravascular and urological access guidewire devices.
Product use
Used to gain ureteral access, to establish a tract, and to assist in the placement, replacement, and exchange
of medical devices during urological and gynecologic procedures. The HiWire, BiWire and Road runner Wire
Guides may also be used for catheter positioning and exchange in a tortuous or kinked ureter, traversing a
large stone in route to the kidney, or in cases demanding enhanced control and high radiopacity.
Device classification
- Risk Class
- Class IIa
- Product Category
- Medical Device
- Product Type
- MD
Registration information
- Registration ID
- ME0000006512SFDAA00193
- Authorization ID
- GHTF-2019-5797
- Status
- Active
- Expire Date
- October 31, 2019
Manufacturer
- Manufacturer Name
- COOK INCORPORATED
Model information
- Model ID(s)
- TSCFB-35-145-1.5 TSCFB-35-145-3 TSCFB-35-145-15 TSCFB-35-180-1.5 TSCFB-35-180-3 TSCFB-38-145-3
Product accessories
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About this record
Access comprehensive regulatory information for Fixed Core Bentson Curved in the Saudi Arabia medical device market through Pure Global AI's free database. This Class IIa device is registered with Saudi Arabia SFDA under registration number ME0000006512SFDAA00193 and manufactured by COOK INCORPORATED.
This page provides complete registration details including product category (Medical Device), manufacturer information, model details, and regulatory compliance data from the official Saudi Arabia SFDA medical device database. Pure Global AI offers free access to Saudi Arabia's complete medical device registry, helping global MedTech companies navigate SFDA regulations efficiently.
Free DatabasePowered by Pure Global AISFDA Official DataClass IIa