Identity
- Trade Name
- Solitaire 2 FDA UDI
- Generic Name
- Bare-metal intracranial vascular stent FDA UDI
- Device Name
- Revascularization Device FDA UDI
- Model / Reference
- SFR2-4-40 FDA UDI
- Description
- Revascularization Device FDA UDI
Identifiers
- Catalog Number
- SFR2-4-40 FDA UDI
- Primary DI / UDI-DI
- 00847536003323 FDA UDI
- FDA Product Code
- NRY FDA UDI
- GMDN Term
- Bare-metal intracranial vascular stent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 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
- Outer Diameter — 4 Millimeter FDA UDILength — 50 Millimeter FDA UDI
Category: Bare-metal intracranial vascular stent
Solitaire 2 by Micro Therapeutics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bare-metal intracranial vascular stent.
- Comaneci Petit — RAPID MEDICAL INC. · Class II
- Surpass Elite — Stryker Corp. · Class III
- Surpass Elite — Stryker Corp. · Class III
- Surpass Elite — Stryker Corp. · Class III
- Neuroform Atlas — Stryker Corp. · Class III
- LVIS — MICROVENTION INC. · Unclassified
- Surpass Streamline — Stryker Corp. · Class III
- LVIS Junior — MICROVENTION INC. · Unclassified
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Micro Therapeutics, Inc.
Sources (1)
- FDA UDI 827caf81-b2de-4707-9d50-3ad57726c940 37 fields · synced May 30, 2026