Avenir Mega Coil System

FDA UDI

Class II (US FDA UDI)

by Shanghai Wallaby Medical Technologies Co., Inc.

Identity

Trade Name: Avenir Mega Coil System FDA UDI
Generic Name: Neurovascular embolization coil FDA UDI
Model / Reference: 18CMG03015 FDA UDI

Identifiers

Primary DI / UDI-DI: 06970908214370 FDA UDI
FDA Product Code: KRD FDA UDI
HCG FDA UDI
GMDN Term: Neurovascular embolization coil FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.3300 FDA UDI
882.5950 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Neurovascular embolization coil

Avenir Mega Coil System by Shanghai Wallaby Medical Technologies Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Shanghai Wallaby Medical Technologies Co., Inc.

Sources (1)

FDA UDI 58cafea9-dfa1-4448-b255-20c6f859fd27 32 fields · synced May 30, 2026