Intelli-C Accessory - Shoulder support for the Intelli-C X-ray system. - Nrt - Nordisk Røntgen Teknik A/S

Duns Number:307332705

Device Description: Shoulder support for the Intelli-C X-ray system. The Shoulder support guides the positioni Shoulder support for the Intelli-C X-ray system. The Shoulder support guides the positioning/support of the patient during angulation towards the Trendelenburg position.

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More Product Details

Catalog Number

-

Brand Name

Intelli-C Accessory

Version/Model Number

03283000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K173631

Product Code Details

Product Code

JAA

Product Code Name

System, X-Ray, Fluoroscopic, Image-Intensified

Device Record Status

Public Device Record Key

91d49ae2-a6a0-4b30-8a3a-f2d747606ce9

Public Version Date

April 19, 2022

Public Version Number

1

DI Record Publish Date

April 11, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NRT - NORDISK RØNTGEN TEKNIK A/S" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 22