AccessGUDID - DEVICE: iScan Coreo (04015630984848)

GUDID

Device Identifier (DI) Information

Brand Name: iScan Coreo
Version or Model: 6303331001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 6303331001
Company Name: VENTANA MEDICAL SYSTEMS, INC.

Primary DI Number: 04015630984848
Issuing Agency: GS1
Commercial Distribution End Date: July 01, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 078501720 *Terms of Use

Device Description: No description.

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?
36287	Pathology information system	A dedicated assembly of devices designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of pathology services and facilities. The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OEO	Automated digital image manual interpretation microscope

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: 63369065-72b8-4ff6-b83b-067b03ad3de9
Public Version Date: November 11, 2020
Public Version Number: 3
DI Record Publish Date: September 21, 2016