Identity
- Trade Name
- ONO Retrieval Device FDA UDI
- Generic Name
- Intravascular extraction catheter-snare FDA UDI
- Device Name
- Retrieval catheter with peel away sheath FDA UDI
- Model / Reference
- ONO12-100 FDA UDI
- Description
- Retrieval catheter with peel away sheath FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860008180605 FDA UDI
- 510(k) Number
- K212988 FDA UDI
- FDA Product Code
- MMX FDA UDI
- GMDN Term
- Intravascular extraction catheter-snare FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5150 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
MR Unsafe FDA UDI
Category: Intravascular extraction catheter-snare
ONO Retrieval Device by Onocor LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intravascular extraction catheter-snare.
- TourniKwik™ — MEDTRONIC, INC. · Class I
- ONE Snare® — Merit Medical Systems, Inc. · Class II
- NCircle — COOK INCORPORATED · Class I
- EN Snare® — Merit Medical Systems, Inc. · Class II
- Amplatz Goose Neck™ — MEDTRONIC, INC. · Class II
- Halo™ Single-Loop Microsnare Kit — Argon Medical Devices, Inc. · Class II
- Halo™ Single-Loop Microsnare Kit — Argon Medical Devices, Inc. · Class II
- EMPOWER™ — Merit Medical Systems, Inc. · Class II
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
- Onocor LLC
Sources (1)
- FDA UDI f0ba35f1-13a8-41a6-a82b-b7a9071b7fc0 35 fields · synced Jun 20, 2026