AccessGUDID - DEVICE: USB-STICK MAGELLAN 7.3 SP2 (09120052071023)

GUDID

Device Identifier (DI) Information

Brand Name: USB-STICK MAGELLAN 7.3 SP2
Version or Model: 30182624 00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 30182624
Company Name: Tecan Austria GmbH

Primary DI Number: 09120052071023
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 301237509 *Terms of Use

Device Description: This media contains the following registered Medical Devices: (DI) 09120052070996 MAGELLAN V7.X (DI) 09120052071009 MAGELLAN TRACKER V7.X

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?
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
JQP	Calculator/Data Processing Module, For Clinical Use

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: 74f962ec-e168-4eac-9f25-d43bfc90cbf7
Public Version Date: March 22, 2022
Public Version Number: 2
DI Record Publish Date: December 01, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
09120052071030	1	09120052071023	In Commercial Distribution	Carton box
09120052071047	1	09120052071023	In Commercial Distribution	Carton box
09120052071054	1	09120052071023	In Commercial Distribution	Carton box
09120052071061	1	09120052071023	In Commercial Distribution	Carton box
09120052071078	1	09120052071023	In Commercial Distribution	Carton box
09120052071085	1	09120052071023	In Commercial Distribution	Carton box