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Table, Surgical C-arm, Contour 115VAC
EUDAMEDFDA UDIClass I (EU MDR)
Ref 058-840
Identity
- Trade Name
- Table, Surgical C-arm, Contour 115VAC EUDAMEDSurgical C-Arm Table, Contour, 115V FDA UDI
- Generic Name
- Fluoroscopy/angiography table, powered FDA UDI
- Device Name
- Surgical C-Arm Tables EUDAMEDThe Surgical C-Arm Tables consists of a cantilevered low attenuation carbon fiber contour tabletop, designed to accommodate portable or ceiling-suspended C-Arm fluoroscopy systems. Model 058-840 includes a 75" radiolucent area, free-float X-Y tabletop, motorized control of height, Isocentric lateral roll, Trendelenburg motions. FDA UDI
- Model / Reference
- 058-840 EUDAMEDFDA UDI
- Description
- The Surgical C-Arm Tables consists of a cantilevered low attenuation carbon fiber contour tabletop, designed to accommodate portable or ceiling-suspended C-Arm fluoroscopy systems. Model 058-840 includes a 75" radiolucent area, free-float X-Y tabletop, motorized control of height, Isocentric lateral roll, Trendelenburg motions. FDA UDI
Identifiers
- Catalog Number
- 058-840 FDA UDI
- Primary DI / UDI-DI
- 00879942070439 EUDAMEDFDA UDI
- Basic UDI-DI
- 085994200610756 EUDAMED
- Direct Marketing DI
- 00879942070439 EUDAMED
- FDA Product Code
- FQO FDA UDI
- EMDN Code
- Z12011202 OPERATING TABLES EUDAMED
- GMDN Term
- Fluoroscopy/angiography table, powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4960 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
Table, Surgical C-arm, Contour 115VAC by Mirion Technologies (Capintec), Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 085994200610756 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Mirion Technologies (Capintec), Inc.
- EUDAMED SRN
- US-MF-000000770
- Authorised Representative
- Atlantico Systems, Ltd. IE-AR-000000208
Sources (2)
- EUDAMED 5111c5fb-95be-43ee-b360-986fc7e20d45 61 fields · synced Jul 22, 2026
- FDA UDI d30fd995-3664-4129-a63e-715187ccaf40 36 fields · synced May 30, 2026