AccessGUDID - DEVICE: CellaVision® Remote Review Software, Team Edition, version 6.0.x (07350040974599)

GUDID

Device Identifier (DI) Information

Brand Name: CellaVision® Remote Review Software, Team Edition, version 6.0.x
Version or Model: CRRS-TE6099
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CRRS-TE6099
Company Name: Cellavision AB

Primary DI Number: 07350040974599
Issuing Agency: GS1
Commercial Distribution End Date: February 15, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 508663101 *Terms of Use

Device Description: The CellaVision remote review software enable up to 5 concurrent remote users to access data collected, stored and processed by CellaVision DM Instruments with the ability to reclassify cells and sign off slides from another location.

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?
43472	Laboratory instrument/analyser application software IVD	An in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOY	Device, Automated Cell-Locating

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K102778	000

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: 5f2fcb94-c0f8-4210-8818-f801e9e7acb6
Public Version Date: March 22, 2022
Public Version Number: 6
DI Record Publish Date: September 23, 2016