PROGNOST - Basic x-ray system table, non-powered - PROTEC GmbH & Co. KG

Duns Number:314629130

Device Description: Basic x-ray system table, non-powered

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More Product Details

Catalog Number

7036-0-1703L

Brand Name

PROGNOST

Version/Model Number

XP

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 27, 2020

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

-

Product Code Details

Product Code

KXJ

Product Code Name

Table, Radiologic

Device Record Status

Public Device Record Key

11972ff3-6e63-486c-8b90-f59b7774d907

Public Version Date

December 16, 2020

Public Version Number

3

DI Record Publish Date

October 28, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PROTEC GMBH & CO. KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 24