Avenir Mega Coil System

GUDID 06970908214431

Shanghai Wallaby Medical Technologies Co., Inc.

Neurovascular embolization coil

• Primary Device ID: 06970908214431
• NIH Device Record Key: 25ff40c3-a8fd-4abb-8ef9-4b2d96d9fe22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avenir Mega Coil System
• Version Model Number: 18CMG05020
• Company DUNS: 544535295
• Company Name: Shanghai Wallaby Medical Technologies Co., Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	06970908214431 [Primary]

FDA Product Code

• KRD: Device, Vascular, For Promoting Embolization

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: 2024-10-21
• Device Publish Date: 2024-10-11

On-Brand Devices [Avenir Mega Coil System]

• 06970908214691: 18HMG12040
• 06970908214684: 18HMG11040
• 06970908214677: 18HMG10040
• 06970908214660: 18HMG09035
• 06970908214653: 18HMG08030
• 06970908214646: 18HMG07030
• 06970908214639: 18HMG07020
• 06970908214622: 18HMG06030
• 06970908214615: 18HMG06020
• 06970908214608: 18HMG06010
• 06970908214592: 18HMG05020
• 06970908214585: 18HMG05015
• 06970908214578: 18HMG05010
• 06970908214561: 18HMG04020
• 06970908214554: 18HMG04015
• 06970908214547: 18HMG04010
• 06970908214530: 18HMG03015
• 06970908214523: 18HMG03010
• 06970908214516: 18HMG03006
• 06970908214509: 18CMG10040
• 06970908214493: 18CMG09035
• 06970908214486: 18CMG08030
• 06970908214479: 18CMG07030
• 06970908214462: 18CMG07020
• 06970908214455: 18CMG06030
• 06970908214448: 18CMG06020
• 06970908214431: 18CMG05020
• 06970908214424: 18CMG05015
• 06970908214417: 18CMG05010
• 06970908214400: 18CMG04020
• 06970908214394: 18CMG04015
• 06970908214387: 18CMG04010
• 06970908214370: 18CMG03015
• 06970908214363: 18CMG03010
• 06970908214356: 18CMG03006