Avenir

GUDID 06970908211294

Embolic Coil

Shanghai Wallaby Medical Technologies Co., Inc.

Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil Neurovascular embolization coil

• Primary Device ID: 06970908211294
• NIH Device Record Key: 69e001de-62b1-4338-8f2c-e60454a49019
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avenir
• Version Model Number: 10CFR06030
• 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: true
• 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	06970908211294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173711

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-03-29
• Device Publish Date: 2021-04-30

On-Brand Devices [Avenir]

• 06970908210983: 10CFN02004
• 06970908211096: 10CFN05008
• 06970908211072: 10CFN04008
• 06970908211065: 10CFN04006
• 06970908211041: 10CFN03008
• 06970908211034: 10CFN03006
• 06970908211027: 10CFN03004
• 06970908211010: 10CFN02504
• 06970908210990: 10CFN02006
• 06970908210976: 10CFN02003
• 06970908210952: 10CFN01504
• 06970908210907: 10HFN06008
• 06970908210877: 10HFN05008
• 06970908210853: 10HFN04010
• 06970908210846: 10HFN04008
• 06970908210839: 10HFN04006
• 06970908210792: 10HFN03010
• 06970908210785: 10HFN03008
• 06970908210778: 10HFN03006
• 06970908210761: 10HFN03004
• 06970908210754: 10HFN02506
• 06970908210747: 10HFN02504
• 06970908210730: 10HFN02503
• 06970908210723: 10HFN02008
• 06970908210716: 10HFN02006
• 06970908210709: 10HFN02004
• 06970908210693: 10HFN02003
• 06970908210686: 10HFN02002
• 06970908210648: 10HFN01503
• 06970908210631: 10HFN01502
• 06970908210624: 10HFN01501
• 06970908210617: 10HFN01002
• 06970908210495: 10HFL05015
• 06970908210488: 10HFL05010
• 06970908210457: 10HFL04010
• 06970908210440: 10HFL04008
• 06970908210433: 10HFL04006
• 06970908210426: 10HFL04004
• 06970908210402: 10HFL03008
• 06970908210396: 10HFL03006
• 06970908210389: 10HFL03004
• 06970908210365: 10CFR10027
• 06970908210358: 10CFR09030
• 06970908210341: 10CFR09023
• 06970908210334: 10CFR08027
• 06970908210327: 10CFR08016
• 06970908210310: 10CFR07024
• 06970908210303: 10CFR07013
• 06970908210297: 10CFR06020
• 06970908210280: 10CFR06011