HistoCore PELORIS B45.5120

GUDID 09349458005573

HistoCore PELORIS 3 Win10/I-Scan Upgrade Kit

LEICA BIOSYSTEMS MELBOURNE PTY LTD

Tissue processor IVD, automated/semi-automated
Primary Device ID09349458005573
NIH Device Record Keyff021a96-6b94-40c3-b212-682364425c8c
Commercial Distribution StatusIn Commercial Distribution
Brand NameHistoCore PELORIS
Version Model NumberHistoCore PELORIS 3 Win10/I-Scan Upgrade Kit
Catalog NumberB45.5120
Company DUNS753184944
Company NameLEICA BIOSYSTEMS MELBOURNE PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109349458005573 [Primary]

FDA Product Code

IEOProcessor, Tissue, Automated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-07
Device Publish Date2023-08-30

On-Brand Devices [HistoCore PELORIS]

09349458005566The scanner can be used to quickly enter the user ID, the ID on a basket’s anti-reflection tag
09349458005559A barcode scanner, a built-in camera and an LCD screen t at displays the images captured by the
09349458004743Accepts most common cassette types and includes configurable dividers that allow for different c
09349458004736Contain cassettes with specimens and are stacked into the retorts. Includes dividers to ensure c
09349458004729Accepts most common cassette types and includes configurable dividers that allow for different c
09349458004712Contain cassettes with specimens and are stacked into the retorts. Includes dividers to ensure c
09349458004811The HistoCore PELORIS 3 dual retort rapid tissue processor automates preparation of tissue sampl
09349458005580HistoCore PELORIS 3 Win10 Upgrade Kit
09349458005573HistoCore PELORIS 3 Win10/I-Scan Upgrade Kit

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.