AccessGUDID - DEVICE: Leica ST5020 Config. 3 (04049188156112)

GUDID

Device Identifier (DI) Information

Brand Name: Leica ST5020 Config. 3
Version or Model: 14905020US3
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 14905020US3
Company Name: Leica Biosystems Nussloch GmbH

Primary DI Number: 04049188156112
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315539452 *Terms of Use

Device Description: The Stainer Leica ST5020 is an automated stain-er for the preparation of histological and cyto-logical routine stainings. It is designed for use in pathology laboratories, and only for performing the following tasks: • Staining of thin sections of tissue specimens or of cytological samples, attached to micro-scope slides • The instrument may be operated only ac¬cording to the instructions contained in this manual.

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):	Yes
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?
15599	Microscope slide stainer IVD	An automated mains electricity (AC-powered) laboratory instrument intended to be used to stain blood, tissue and/or other clinical specimens fixed to microscope examination slides, using one or more biological or cytochemical staining solutions in preparation for subsequent microscopic analysis. The device operates with minimal technician involvement and complete automation of all procedural steps.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPA	Slide stainer, automated

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
Special Storage Condition, Specify:

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify:

Device Record Status

Public Device Record Key: ae37a848-7d70-4109-813d-d9c84c5b5abf
Public Version Date: December 17, 2018
Public Version Number: 1
DI Record Publish Date: November 16, 2018