AccessGUDID - DEVICE: Grid entity (04260502640098)

GUDID

Device Identifier (DI) Information

Brand Name: Grid entity
Version or Model: DE2
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 7054-0-5320
Company Name: PROTEC GmbH & Co. KG

Primary DI Number: 04260502640098
Issuing Agency: GS1
Commercial Distribution End Date: December 16, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 314629130 *Terms of Use

Device Description: X-ray film cassette holder

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?
14473	X-ray film cassette holder	A device designed to position and hold the cassettes containing x-ray film during medical or dental imaging or radiation therapy procedures. It is used in conjunction with multiformat cameras and diagnostic imaging and radiation therapy modalities, e.g., nuclear medicine systems, ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IXY	Holder, Radiographic Cassette, Wall-Mounted

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: 0572b130-28d3-4a8e-a866-e84126914d24
Public Version Date: December 17, 2019
Public Version Number: 3
DI Record Publish Date: November 09, 2016