Identity
- Trade Name
- Nexus FDA UDI
- Generic Name
- Neurovascular embolization coil FDA UDI
- Device Name
- Detachable Coil FDA UDI
- Model / Reference
- X-6-12-T10-MC FDA UDI
- Description
- Detachable Coil FDA UDI
Identifiers
- Catalog Number
- X-6-12-T10-MC FDA UDI
- Primary DI / UDI-DI
- 00836462019737 FDA UDI
- 510(k) Number
- K060625 FDA UDI
- FDA Product Code
- HCG FDA UDI
- GMDN Term
- Neurovascular embolization coil FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5950 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 12 Centimeter FDA UDIOuter Diameter — 6 Millimeter FDA UDIOuter Diameter — 3.5 Millimeter FDA UDI
Category: Neurovascular embolization coil
Nexus by Micro Therapeutics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neurovascular embolization coil.
- HydroSoft Helical — MICROVENTION INC. · Class II
- Target — Stryker Corp. · Class II
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- WEB Aneurysm Embolization System — MICROVENTION INC. · Class III
- HydroFill Helical — MICROVENTION INC. · Class II
- TARGET — Stryker Corp. · Class II
- HydroFill Helical — MICROVENTION INC. · Class II
- V-Trak — MICROVENTION INC. · Class II
Cleared under the same submission
K060625 also covers:
- Nexus — Micro Therapeutics, Inc.
- Nexus — Micro Therapeutics, Inc.
- Nexus — Micro Therapeutics, Inc.
- Nexus — Micro Therapeutics, Inc.
- Nexus — Micro Therapeutics, Inc.
- Nexus — Micro Therapeutics, Inc.
- Nexus — Micro Therapeutics, Inc.
- Nexus — Micro Therapeutics, Inc.
- Nexus — Micro Therapeutics, Inc.
- Nexus — Micro Therapeutics, Inc.
- Nexus — Micro Therapeutics, Inc.
- Nexus — Micro Therapeutics, Inc.
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
- Micro Therapeutics, Inc.
Sources (1)
- FDA UDI 8be156df-d534-4d52-a893-2bd811ef3fe8 37 fields · synced Jun 8, 2026