AccessGUDID - DEVICE: Leica ST4020 China (04049188203908)

GUDID

Device Identifier (DI) Information

Brand Name: Leica ST4020 China
Version or Model: 000000014050954854
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 14050954854
Company Name: Leica Biosystems Nussloch GmbH

Primary DI Number: 04049188203908
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315539452 *Terms of Use

Device Description: The Leica Small Linear Stainer ST4020 is used for the automated preparation of routine histo¬logical and cytological stains. It is i ntended for use in pathology laboratories to assist with the following tasks: • Staining thin tissue sections or cytological specimens on slides. Frozen sections can also be stained. • The instrument may be operated only ccording 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: c113f26a-3bb8-44bc-a5bc-5a4ee3724ee6
Public Version Date: January 04, 2019
Public Version Number: 1
DI Record Publish Date: December 04, 2018