Guider Softip XF; GUIDER/40DEG XF/7FR/90CM, Model number: H965100430 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system. (UDI Z-0333-2017)
Manufactured by Stryker Neurovascular
Device Regulatory Overview
The Guider Softip XF; GUIDER/40DEG XF/7FR/90CM, Model number: H965100430 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system. (Model/Catalog Number: Unspecified) is a medical device manufactured by Stryker Neurovascular. This product is indexed under FDA Product Code / Category Classification Lots 18709130, 18709234, 18709643, 18774858, 18775292; Expiration 12/31/2019. Lots 18785727, 18785933, 18849986; Expiration 01/31/2019. within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
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Technical Specifications
- Model Number
- N/A
- Product Code / EMDN
- Lots 18709130, 18709234, 18709643, 18774858, 18775292; Expiration 12/31/2019. Lots 18785727, 18785933, 18849986; Expiration 01/31/2019.
- Device Name
- Guider Softip XF; GUIDER/40DEG XF/7FR/90CM, Model number: H965100430 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.
- Database Sync Date
- 2026-08-09 10:06:38
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Guider Softip XF; GUIDER/40DEG XF/7FR/90CM, Model number: H965100430 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.?
The registered manufacturer of record for Guider Softip XF; GUIDER/40DEG XF/7FR/90CM, Model number: H965100430 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system. is Stryker Neurovascular.
What is the Primary UDI-DI identifier for Guider Softip XF; GUIDER/40DEG XF/7FR/90CM, Model number: H965100430 . Cardiology: Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the placement of interventional devices into the neurovascular system.?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-0333-2017.
What classification code is assigned to this device?
This device is registered under product classification code Lots 18709130, 18709234, 18709643, 18774858, 18775292; Expiration 12/31/2019. Lots 18785727, 18785933, 18849986; Expiration 01/31/2019..
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