Wedge MCWED21160-088

GUDID 00842429119396

Wedge XL

MICROVENTION INC.

Vascular microcatheter

• Primary Device ID: 00842429119396
• NIH Device Record Key: 24a93de4-7504-4517-80f6-2894bb977b28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wedge
• Version Model Number: MCWED21160-088
• Catalog Number: MCWED21160-088
• 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(888) 775-0182
• Email: customerservice@microvention.com
• Phone: +1(888) 775-0182
• Email: customerservice@microvention.com
• Phone: +1(888) 775-0182
• Email: customerservice@microvention.com
• Phone: +1(888) 775-0182
• Email: customerservice@microvention.com
• Phone: +1(888) 775-0182
• Email: customerservice@microvention.com
• Phone: +1(888) 775-0182
• Email: customerservice@microvention.com
• Phone: +1(888) 775-0182
• Email: customerservice@microvention.com
• Phone: +1(888) 775-0182
• Email: customerservice@microvention.com
• Phone: +1(888) 775-0182
• Email: customerservice@microvention.com
• Phone: +1(888) 775-0182
• Email: customerservice@microvention.com
• Phone: +1(888) 775-0182
• Email: customerservice@microvention.com
• Phone: +1(888) 775-0182
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry. Keep away from sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842429119396 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232542

FDA Product Code

• QJP: Catheter, Percutaneous, Neurovasculature

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: 2024-10-28
• Device Publish Date: 2024-10-18

On-Brand Devices [Wedge]

• 00816777025838: Microcatheter
• 00842429119396: Wedge XL
• 00816777028686: Wedge