Identity
- Trade Name
- OrionTM FDA UDI
- Generic Name
- Vascular microcatheter FDA UDI
- Device Name
- MICROCATHETER 105-5098-150 V02 ORION FDA UDI
- Model / Reference
- 105-5098-150 FDA UDI
- Description
- MICROCATHETER 105-5098-150 V02 ORION FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847536027107 FDA UDI
- 510(k) Number
- K113289 FDA UDI
- FDA Product Code
- KRA FDA UDI
- GMDN Term
- Vascular microcatheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1210 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Ethylene Oxide FDA UDI
MR Conditional FDA UDI
OrionTM by Micro Therapeutics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 5ceb347b-53c8-4544-a8eb-5b9f4e713010 36 fields · synced May 31, 2026