WaveSelect

GUDID 06945258302107

Enlight Medical Technologies(Shenzhen) Co., Ltd.

Neurovascular embolization coil

• Primary Device ID: 06945258302107
• NIH Device Record Key: 00c960ba-43b0-4416-8d47-56d22c11b669
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WaveSelect
• Version Model Number: GW1010
• Company DUNS: 545380342
• Company Name: Enlight Medical Technologies(Shenzhen) Co., Ltd.
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06945258302107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240871

FDA Product Code

• MOF: Guide, Wire, Catheter, 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: 2025-08-08
• Device Publish Date: 2025-07-31

On-Brand Devices [WaveSelect]

• 06945258302114: GW1410
• 06945258302107: GW1010