AccessGUDID - DEVICE: Mikroscan (00860002275604)

GUDID

Device Identifier (DI) Information

Brand Name: Mikroscan
Version or Model: SL5
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MIKROSCAN TECHNOLOGIES, INC.

Primary DI Number: 00860002275604
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079395952 *Terms of Use

Device Description: The dual mode SL5 system from Mikroscan offers the user two completely separate and distinctly different capabilities in one convenient device. The user selects either the live microscope mode using a fully functional, remotely controlled robotic microscope or a static digital pathology scanner for the creation of whole-slide images*. The protection features of the equipment may be impaired if the device is used in a manner not specified by Mikroscan. *For Research Use Only. Not for use in diagnostic procedures.

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?
62575	Microscope slide digital imaging scanner IVD	A mains electricity (AC-powered) device designed to be used in a histopathology laboratory to scan clinical specimens on microscope slides, at a microscopic level, to produce images in a digital format. Also known as a whole slide scanner or digital pathology slide scanning system, it is a bench-top unit with slide tray slots, high-resolution cameras, a user interface, and integrated software for image creation, viewing, and management to aid the pathologist to review and interpret slide images.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IBJ	Light, Microscope

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 875f6c13-ff17-4e1f-bda8-754ea747eabb
Public Version Date: January 10, 2020
Public Version Number: 1
DI Record Publish Date: January 02, 2020