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Intelli-C Accessory
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 03285000Model CFP Accessories
Identity
- Trade Name
- Side Bar EUDAMEDIntelli-C Accessory FDA UDI
- Generic Name
- Bedrail FDA UDI
- Device Name
- Side Bar for the Intelli-C X-ray system. A long side bar to be fixed in any position along the table top designed to support the patient while rolling over for various examinations. FDA UDI
- Model / Reference
- 03285000 EUDAMEDFDA UDICFP Accessories EUDAMED
- Description
- Side Bar for the Intelli-C X-ray system. A long side bar to be fixed in any position along the table top designed to support the patient while rolling over for various examinations. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05713464000428 EUDAMEDFDA UDI
- Basic UDI-DI
- 571346413200AG EUDAMED
- Direct Marketing DI
- 05713464000428 EUDAMED
- 510(k) Number
- K173631 FDA UDI
- FDA Product Code
- JAA FDA UDIOWB FDA UDI
- EMDN Code
- Z11039080 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Bedrail FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1650 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- 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
No
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: Bedrail
Intelli-C Accessory by Nrt - Nordisk Røntgen Teknik A/S — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Bedrail.
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- MERITS — MERITS HEALTH PRODUCTS., INC. · Class I
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- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Composite Swing Rail — Dynarex Corp. · Class I
- Expansion Kit for D300 — Dynarex Corp. · Class I
Cleared under the same submission
K173631 also covers:
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
- Intelli-C Accessory — Nrt - Nordisk Røntgen Teknik A/S
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nrt - Nordisk Røntgen Teknik A/S
Sources (2)
- FDA UDI 7ad43f95-c248-4c31-9baf-b9d18dc3b049 35 fields · synced Jun 18, 2026
- EUDAMED 531a7ed7-a0e0-4f1e-bf3e-57cf7fcfa13f 61 fields · synced Jun 18, 2026