FDA.report

Epredia

Primary DI
00673693083751
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Disposable Base Molds
Catalog number
58950
Device description
Disposable Base Molds are designed for use with all standard size tissue cassettes and embedding rings. They are molded from rigid plastic and the block design provides greater base support and smaller cutting surfaces. Cleaning associated with metal molds is not required and the transparency facilitates tissue orientation. Disposable base molds come in four different sizes to accommodate different tissue sizes.
Published
2024-08-01
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
true

Related Records

Product Codes

CodeName
KERContainer, Embedding

Product Code Classifications

CodeDeviceSpecialtyClass
KERContainer, EmbeddingPathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00673693083751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693083751006736930837516736930837510673693083751

GMDN Terms

TermDefinition
Tissue embedding mould IVD, single-useA plastic container of square or rectangular shape intended to be used to embed tissue specimens into an embedding medium (e.g., paraffin wax) to form a solid block, which is subsequently cut into thin sections for processing and analysis of the tissue specimen. It is typically made of synthetic polymer materials (e.g., plastic) This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
929504710
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06971182571166Embedding CassetteDakewe (Shenzhen) Medical Equipment Co., Ltd.KER2024-12-27
06971182571173Embedding CassetteDakewe (Shenzhen) Medical Equipment Co., Ltd.KER2024-12-27
06971182571180Embedding CassetteDakewe (Shenzhen) Medical Equipment Co., Ltd.KER2024-12-27
06971182571197Embedding CassetteDakewe (Shenzhen) Medical Equipment Co., Ltd.KER2024-12-27
00673693227506EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-10-08
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00673693227520EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-10-08
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00673693214254EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-08-02
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00615233081810Tissue-Tek® Quick-Ray™SAKURA FINETEK U.S.A., INC.KER2020-03-17
00615233081827Tissue-Tek® Quick-Ray™SAKURA FINETEK U.S.A., INC.KER2020-03-17
00615233081834Tissue-Tek® Quick-Ray™SAKURA FINETEK U.S.A., INC.KER2020-03-17
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10615233078787Cryomold®SAKURA FINETEK U.S.A., INC.KER2020-03-17
00615233078346Tissue-Tek® NanoMold™SAKURA FINETEK U.S.A., INC.KER2020-01-27