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Intelli-C Accessory

FDA UDI

Class II (US FDA UDI)

by Nrt - Nordisk Røntgen Teknik A/S

Identity

Trade Name
Intelli-C Accessory FDA UDI
Generic Name
Radiological arm/leg positioner FDA UDI
Device Name
A set of three adjustable straps with quick-fit Velcro fastenings restrains the patient in a fixed position for the Intelli-C X-ray system FDA UDI
Model / Reference
21320012 FDA UDI
Description
A set of three adjustable straps with quick-fit Velcro fastenings restrains the patient in a fixed position for the Intelli-C X-ray system FDA UDI

Identifiers

Primary DI / UDI-DI
05713464000541 FDA UDI
510(k) Number
K173631 FDA UDI
FDA Product Code
OWB FDA UDI
JAA FDA UDI
GMDN Term
Radiological arm/leg positioner 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Radiological arm/leg positioner

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

Similar devices

Also classified as Radiological arm/leg positioner.

Cleared under the same submission

K173631 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nrt - Nordisk Røntgen Teknik A/S

Sources (1)

  • FDA UDI 161cc3f2-2f22-4dd2-a18c-f365f3feb9e1 35 fields · synced Jun 1, 2026