AccessGUDID - DEVICE: PROGNOST (04260502640043)

GUDID

Device Identifier (DI) Information

Brand Name: PROGNOST
Version or Model: XS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 7034-0-0000
Company Name: PROTEC GmbH & Co. KG

Primary DI Number: 04260502640043
Issuing Agency: GS1
Commercial Distribution End Date: December 15, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 314629130 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40654	Basic diagnostic x-ray system table, non-powered	A non-powered table that is a component of a basic diagnostic x-ray system designed to position and support a patient during a variety of routine/planar or speciality diagnostic procedures requiring the use of a diagnostic x-ray system; it is not a planar tomography nor computed tomography (CT) table. It can be a stationary or mobile unit and is made of radiolucent materials with low x-ray attenuation coefficients. It is not intended for use during interventional radiology/surgery.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KXJ	Table, Radiologic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Atmospheric Pressure: between 700 and 1060 millibar
Handling Environment Humidity: between 30 and 70 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 500 and 1060 millibar
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 85ad85e3-cdcf-4a66-b7ef-c133f276e998
Public Version Date: December 16, 2020
Public Version Number: 3
DI Record Publish Date: October 28, 2016