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Intelli-C Accessory

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 03284050Model CFP Accessories

by Nrt - Nordisk Røntgen Teknik A/S

Identity

Trade Name
Radiation Shield with top shield EUDAMED
Intelli-C Accessory FDA UDI
Generic Name
Radiation shielding curtain FDA UDI
Device Name
Radiation Shield with Top shield for the Intelli-C X-ray system. A lead curtain for protection against stray radiation during x-ray examination. A cover above the table protects the user against stray radiation from the patient. FDA UDI
Model / Reference
03284050 EUDAMEDFDA UDI
CFP Accessories EUDAMED
Description
Radiation Shield with Top shield for the Intelli-C X-ray system. A lead curtain for protection against stray radiation during x-ray examination. A cover above the table protects the user against stray radiation from the patient. FDA UDI

Identifiers

Primary DI / UDI-DI
05713464000411 EUDAMEDFDA UDI
Basic UDI-DI
571346413200AG EUDAMED
Direct Marketing DI
05713464000411 EUDAMED
510(k) Number
K173631 FDA UDI
FDA Product Code
JAA FDA UDI
OWB FDA UDI
EMDN Code
Z11039080 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
GMDN Term
Radiation shielding curtain FDA UDI

Classification

Device Class
Class I EUDAMED
Class 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: Radiation shielding curtain

Intelli-C Accessory by Nrt - Nordisk Røntgen Teknik A/S — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Radiation shielding curtain.

Cleared under the same submission

K173631 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nrt - Nordisk Røntgen Teknik A/S

Sources (2)

  • FDA UDI 58279745-9fae-45f6-8b84-7d9d2031de4b 35 fields · synced Jul 9, 2026
  • EUDAMED 59fa016c-03a3-43c5-8dd2-41c3ca039018 61 fields · synced Jul 9, 2026