DEVICE: AxiumTM (00847536023222)
Device Identifier (DI) Information
AxiumTM
FC-18-50-3D
In Commercial Distribution
Micro Therapeutics, Inc.
FC-18-50-3D
In Commercial Distribution
Micro Therapeutics, Inc.
FRAMING COIL FC-18-50-3D V01
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
60940 | Neurovascular embolization coil |
A non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HCG | DEVICE, NEUROVASCULAR EMBOLIZATION |
KRD | Device, Vascular, for Promoting Embolization |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K162704 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in a dry, cool place |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
51433ad2-d777-4903-801e-7f10fbab9d11
February 05, 2021
5
February 04, 2017
February 05, 2021
5
February 04, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
Corporate.UDI@medtronic.com