SOFIA 88 DA8115ST

GUDID 00842429117705

SOFIA 88 - 115cm

MICROVENTION INC.

Vascular guide-catheter, single-use

• Primary Device ID: 00842429117705
• NIH Device Record Key: 166e158b-e3bc-4a42-b1a8-2b99db08f6a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOFIA 88
• Version Model Number: DA8115ST-DAC-US
• Catalog Number: DA8115ST
• Company DUNS: 003263105
• Company Name: MICROVENTION INC.
• Device Count: 1
• DM Exempt: false
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com
• Phone: +1(714) 247-8000
• Email: customerservice@microvention.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842429117705 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K214024

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: 2023-06-23
• Device Publish Date: 2023-06-15

Devices Manufactured by MICROVENTION INC.

• 00842429108444 - Sofia: 2024-10-28 Sofia 6F-115cm STR
• 00842429108451 - Sofia: 2024-10-28 Sofia 6F-125cm STR
• 00842429108468 - Sofia: 2024-10-28 Sofia 6F-131cm STR
• 00842429108475 - Sofia: 2024-10-28 Sofia 6F-125cm STR
• 00842429118092 - Access: 2024-10-28 Sofia EX 5F - 115cm STR
• 00842429119396 - Wedge: 2024-10-28 Wedge XL
• 00842429108482 - Sofia: 2024-08-14 Sofia 6F-131cm STR
• 00842429117705 - SOFIA 88: 2023-06-23SOFIA 88 - 115cm
• 00842429117705 - SOFIA 88: 2023-06-23 SOFIA 88 - 115cm