WEDGE MCWED21160

GUDID 00816777028686

Wedge

MICROVENTION INC.

Vascular microcatheter

• Primary Device ID: 00816777028686
• NIH Device Record Key: 0e2008f9-7f6e-4670-a3bd-be7dc5b12419
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WEDGE
• Version Model Number: MCWED21160-US
• Catalog Number: MCWED21160
• 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: 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

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

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
• 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	00816777028686 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172014

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: 2025-05-08
• Device Publish Date: 2025-04-30

On-Brand Devices [WEDGE]

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