DEVICE: Concerto Detachable Coil System (00763000307240)

Device Identifier (DI) Information

Concerto Detachable Coil System
NV-10-20-HELIX
Not in Commercial Distribution

Micro Therapeutics, Inc.
00763000307240
GS1
August 30, 2023
1
826110710 *Terms of Use
COIL NV-10-20-HELIX V07
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Device Characteristics

MR Conditional
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?
60941 Non-neurovascular embolization coil
A non-bioabsorbable, implantable device intended to induce a thrombosis within a non-neurovascular blood vessel to treat an aneurysm and/or non-neurovascular arteriovenous malformation (AVM); it is not intended for neurovascular application. It is in the form of a metal or metal/synthetic polymer wire which coils upon deployment within an aneurysm or the vasculature surrounding a malformation; 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
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FDA Product Code

[?]
Product Code Product Code Name
KRD Device, Vascular, for Promoting Embolization
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K090046 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: less than 50 Degrees Celsius
Special Storage Condition, Specify: store in a cool dry place
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

df1a9e7f-fa4f-4b6f-b991-93c2d08ee77a
September 25, 2024
3
September 24, 2020
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
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