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ConcertoTM

FDA UDI

Class II (US FDA UDI)

by Micro Therapeutics, Inc.

Identity

Trade Name
ConcertoTM FDA UDI
Generic Name
Non-neurovascular embolization coil FDA UDI
Device Name
NV-5-10-HELIX CONCERTO HELIX 5MMX10CM FDA UDI
Model / Reference
NV-5-10-HELIX FDA UDI
Description
NV-5-10-HELIX CONCERTO HELIX 5MMX10CM FDA UDI

Identifiers

Primary DI / UDI-DI
00847536013469 FDA UDI
510(k) Number
K090046 FDA UDI
FDA Product Code
KRD FDA UDI
GMDN Term
Non-neurovascular embolization coil FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.3300 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI
MRI Safety
MR Conditional FDA UDI

ConcertoTM by Micro Therapeutics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K090046 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Micro Therapeutics, Inc.

Sources (1)

  • FDA UDI 4ad4110f-8c07-421a-9bab-c2460412e309 37 fields · synced Jun 1, 2026