Intelli-C Accessory - End-of table radiation shield for the Intelli-C - Nrt - Nordisk Røntgen Teknik A/S

Duns Number:307332705

Device Description: End-of table radiation shield for the Intelli-C X-ray system. A lead curtain for protectio End-of table radiation shield for the Intelli-C X-ray system. A lead curtain for protection against stray radiation of a caretaker positioned near the patients' head.

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More Product Details

Catalog Number

-

Brand Name

Intelli-C Accessory

Version/Model Number

03284200

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

319c92ab-4f1d-4538-a475-aa1c8d54e70c

Public Version Date

April 26, 2021

Public Version Number

1

DI Record Publish Date

April 16, 2021

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