Identity
- Trade Name
- OEC FDA UDI
- Generic Name
- Mobile general-purpose fluoroscopic x-ray system, digital FDA UDI
- Device Name
- MEDICAL DEVICE, UDI LABEL PLACEMENT, OEC One FDA UDI
- Model / Reference
- One FDA UDI
- Description
- MEDICAL DEVICE, UDI LABEL PLACEMENT, OEC One FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682125604 FDA UDI
- FDA Product Code
- OWB FDA UDIOXO FDA UDIJAA FDA UDI
- GMDN Term
- Mobile general-purpose fluoroscopic x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Mobile general-purpose fluoroscopic x-ray system, digital
Oec by GE Hualun Medical Systems Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mobile general-purpose fluoroscopic x-ray system, digital.
- Ziehm Vision RFD 3D — Ziehm Imaging, Inc. · Class II
- SURGIVISIO DEVICE — ECENTIAL ROBOTICS · Class II
- Flat panel sensor holder — FUJIFILM Corporation · Class II
- Ziehm Vision FD — Ziehm Imaging, Inc. · Class II
- FDR CROSS — FUJIFILM Corporation · Class II
- SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED — Gemss Medical Systems Co., Ltd. · Class II
- Zenition — Philips Medical Systems Nederland B.V. · Class II
- Genoray — GENORAY CO., LTD. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GE Hualun Medical Systems Co., Ltd
Sources (1)
- FDA UDI 02dbb371-fce5-45cc-bbcc-372735b003c3 34 fields · synced May 30, 2026