AccessGUDID - DEVICE: Leica Biosystems CytoVision HD Image, Dell 5810 RAID1 Win 7 Pro (00849832009887)

GUDID

Device Identifier (DI) Information

Brand Name: Leica Biosystems CytoVision HD Image, Dell 5810 RAID1 Win 7 Pro
Version or Model: 23DKI5817
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Leica Biosystems Richmond, Inc.

Primary DI Number: 00849832009887
Issuing Agency: GS1
Commercial Distribution End Date: March 11, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 082930884 *Terms of Use

Device Description: Leica Biosystems CytoVision HD Image, Dell 5810 RAID1 Win 7 Pro

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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36698	Hard-disc-station computer drive	A device designed to be connected to one or more computers in order to provide more hard disc storage capacity.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOY	DEVICE, AUTOMATED CELL-LOCATING

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
Special Storage Condition, Specify:

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify:

Device Record Status

Public Device Record Key: 43d2a4b1-05f4-42d3-b36a-1f8091349f7c
Public Version Date: March 12, 2025
Public Version Number: 4
DI Record Publish Date: September 17, 2016