Sofia EX 5F - 115cm STR ISC5115ST

GUDID 00842429101582

MICROVENTION INC.

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use

• Primary Device ID: 00842429101582
• NIH Device Record Key: 5839a43f-4e2d-49d4-a17a-fd12e0c47cbd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sofia EX 5F - 115cm STR
• Version Model Number: ISC5115ST
• Catalog Number: ISC5115ST
• Company DUNS: 003263105
• Company Name: MICROVENTION INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com
• Phone: (714) 247-8000
• Email: customerservice@microvention.com

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00842429101582 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182602

FDA Product Code

• DQY: Catheter, Percutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-03
• Device Publish Date: 2019-09-25

Devices Manufactured by MICROVENTION INC.

• 00842429117705 - SOFIA 88: 2023-06-23 SOFIA 88 - 115cm
• 00842429117743 - Stent: 2023-05-04 LVIS EVO
• 00842429117750 - Stent: 2023-05-04 LVIS EVO
• 00842429117767 - Stent: 2023-05-04 LVIS EVO
• 00842429117774 - Stent: 2023-05-04 LVIS EVO
• 00842429117781 - Stent: 2023-05-04 LVIS EVO
• 00842429117798 - Stent: 2023-05-04 LVIS EVO
• 00842429117804 - Stent: 2023-05-04 LVIS EVO