Intelli-C Accessory - A set of leg supports for the Intelli-C X-ray - Nrt - Nordisk Røntgen Teknik A/S

Duns Number:307332705

Device Description: A set of leg supports for the Intelli-C X-ray system for gynecological and urological exa A set of leg supports for the Intelli-C X-ray system for gynecological and urological examinations. The leg supports can be placed freely along the table top.

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More Product Details

Catalog Number

-

Brand Name

Intelli-C Accessory

Version/Model Number

03282600

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

595a3a8a-461b-4c08-9afd-49983de05fc6

Public Version Date

October 28, 2020

Public Version Number

1

DI Record Publish Date

October 20, 2020

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