AccessGUDID - DEVICE: HistoCore PELORIS (09349458004736)

GUDID

Device Identifier (DI) Information

Brand Name: HistoCore PELORIS
Version or Model: Basket Spaced
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S45.4505
Company Name: LEICA BIOSYSTEMS MELBOURNE PTY LTD

Primary DI Number: 09349458004736
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 753184944 *Terms of Use

Device Description: Contain cassettes with specimens and are stacked into the retorts. Includes dividers to ensure cassettes are correctly spaced for optimal processing.

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?
57859	Tissue processor IVD, automated/semi-automated	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the processing of clinical tissue specimens [e.g., fixation (encapsulation in paraffin wax), dehydration, infiltration] in preparation for subsequent cytological or histological examination. The device may be a single unit or modular assembly.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IEO	Processor, Tissue, 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5c1dc9fc-8f70-4946-a28f-bbe55057baf7
Public Version Date: September 16, 2022
Public Version Number: 2
DI Record Publish Date: July 18, 2022