AccessGUDID - DEVICE: EAGLESOFT (00350227000070)

GUDID

Device Identifier (DI) Information

Brand Name: EAGLESOFT
Version or Model: 18.10
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PATTERSON TECHNOLOGY CENTER

Primary DI Number: 00350227000070
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 062232311 *Terms of Use

Device Description: LORIN LIBRARY

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):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Radiology picture archiving and communication system application software	An individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to picture archiving and communication system (PACS) used for radiology. A basic set of applications programs and routines are included with such a PACS and can be upgraded to correct programming errors or to add new system capabilities. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

GMDN Preferred Term Name

GMDN Definition

Radiology picture archiving and communication system application software

An individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to picture archiving and communication system (PACS) used for radiology. A basic set of applications programs and routines are included with such a PACS and can be upgraded to correct programming errors or to add new system capabilities. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

FDA Product Code

[?]

Product Code	Product Code Name
LLZ	System, Image Processing, Radiological

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 835472cb-ed94-414c-b46e-f8ebe9b32338
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016