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

Duns Number:314629130

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

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More Product Details

Catalog Number

7034-0-0000

Brand Name

PROGNOST XS

Version/Model Number

table top 196,3x65,5cm composite fiber

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 21, 2021

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

6ca81dfa-eed5-4b2d-84bf-d5fcf6a6d51b

Public Version Date

December 14, 2021

Public Version Number

2

DI Record Publish Date

December 15, 2020

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