Avenir

FDA UDI

Class II (US FDA UDI)

by Shanghai Wallaby Medical Technologies Co., Inc.

Identity

Trade Name: Avenir FDA UDI
Generic Name: Neurovascular embolization coil FDA UDI
Device Name: Embolic Coil FDA UDI
Model / Reference: 10USH03508 FDA UDI
Description: Embolic Coil FDA UDI

Identifiers

Primary DI / UDI-DI: 06970908212666 FDA UDI
FDA Product Code: HCG FDA UDI
KRD FDA UDI
GMDN Term: Neurovascular embolization coil FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5950 FDA UDI
870.3300 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 by Shanghai Wallaby Medical Technologies Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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HydroFill Helical — MICROVENTION INC. · Class II
TARGET — Stryker Corp. · Class II

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 2901bd14-a53c-42b0-91b8-0dc01eee0cb4 33 fields · synced May 31, 2026