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Imaging Extension, Long, OPERON D 750-D
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 8000099Model Surgical and Diagnostic Devices
by Qfix
Identity
- Trade Name
- Imaging Extension, Long, OPERON D 750-D FDA UDI
- Generic Name
- Universal operating table top FDA UDI
- Device Name
- Imaging Extension, Long, OPERON D 750-D FDA UDI
- Model / Reference
- 8000099 EUDAMEDFDA UDISurgical and Diagnostic Devices EUDAMED
- Description
- Imaging Extension, Long, OPERON D 750-D FDA UDI
Identifiers
- Catalog Number
- 8000099 FDA UDI
- Primary DI / UDI-DI
- 10841962110492 EUDAMEDFDA UDI
- Basic UDI-DI
- 8419621SURGDXAA EUDAMED
- FDA Product Code
- KXJ FDA UDI
- EMDN Code
- Z12019099 VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - OTHER EUDAMED
- GMDN Term
- Universal operating table top FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1980 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 44 Inch FDA UDIWidth — 21 Inch FDA UDI
Category: Universal operating table top
Imaging Extension, Long, OPERON D 750-D by Qfix — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Universal operating table top.
- Shoulder support** (pr.) — Skytron, LLC · Class I
- AUXILIARY IMAGING TOP — Mizuho Orthopedic Systems, Inc. · Class I
- Back plate — Maquet, Inc. · Class I
- Back plate — Maquet, Inc. · Class I
- SchureMed — SCHUERCH CORPORATION · Class I
- Shoulder module — Maquet, Inc. · Class I
- Carbon fibre back plate — Maquet, Inc. · Class I
- Carbon fibre back plate — Maquet, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Qfix
Sources (2)
- FDA UDI 48823b1d-81ad-44ab-a597-1c3bb84b4f0d 36 fields · synced Jun 19, 2026
- EUDAMED e19fc584-cfb1-4cd8-b315-b3e37e3bfc15 61 fields · synced Jun 19, 2026