FDA UDI In Commercial Distribution 🇺🇸 United States

Avenir Mega Coil System

DI: 06970908214363 · Model: 18CMG03010 · Shanghai Wallaby Medical Technologies Co., Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Avenir Mega Coil System
Primary DI
06970908214363
Version / Model
18CMG03010
Company Name
Shanghai Wallaby Medical Technologies Co., Inc.
Labeler DUNS
544535295
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-10-11
Public Version
1
Public Version Date
2024-10-21
Public Version Status
New
Public Device Record Key
6a9d6bfd-52dc-4bb9-98bd-2db31b23cd4d

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
MR Conditional
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
KRD Device, Vascular, For Promoting Embolization
HCG Device, Neurovascular Embolization

GMDN Terms

Code Name
60940 Neurovascular embolization coil

Identifiers

Type ID
Primary 06970908214363