FDA.report

Epredia

Primary DI
05051663517621
Brand
Epredia
Company
SHANDON DIAGNOSTICS LIMITED
Model
Downdraft extraction duct adaptor kit
Catalog number
A84110045
Device description
Revos Tissue Processor accessory
Published
2024-02-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IEOProcessor, Tissue, Automated

Product Code Classifications

CodeDeviceSpecialtyClass
IEOProcessor, Tissue, AutomatedPathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05051663517621PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05051663517621050516635176215051663517621

GMDN Terms

TermDefinition
Tissue processor IVD, automated/semi-automatedAn 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
219103512
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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05051663010528EprediaHM 325 Rotary Microtome (UK made)902100-UK2024-05-10
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05051663517362EprediaSLIP HOPPER 24x40mm #1.5A792100502024-02-16
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05051663517393EprediaBasket Stand CompleteA792100562024-02-16
05051663517423EprediaSakura DRS2000 Basket (5)A792100662024-02-16
05051663517430EprediaSakura DRS2000 Basket (5)A792100672024-02-16
05051663517447EprediaSakura DRS2000 Basket (5)A792100682024-02-16
05051663517454EprediaVaristain V24-4 BasketA792100692024-02-16
05051663517461EprediaLeica Basket (5)A792100722024-02-16
05051663517478EprediaLeica Basket (5)A792100732024-02-16

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