FDA.reportPublic FDA data

Epredia

Primary DI
00673693224130
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Disposable Base Molds
Catalog number
41742
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
2024-08-02
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

Product Codes#

Code, Name table
CodeName
KERContainer, Embedding

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KERContainer, EmbeddingPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673693224130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693224130006736932241306736932241300673693224130

GMDN Terms#

Term, Definition table
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 table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00673693181723EprediaPen-Fix™61052024-11-19
00673693063494EprediaMicrotome Knife, 12 CM, C22220042024-10-29
00673693063500EprediaMicrotome Knife, 16 CM, C1520202024-10-29
00673693063753EprediaMicrotome Knife, 30CM, C1520502024-10-29
00673693063760EprediaMicrotome Knife, 12 CM, D1520602024-10-29
00673693063777EprediaMicrotome Knife, 16 CM, D1520702024-10-29
00673693063784EprediaMicrotome Knife, 22 CM, D1520802024-10-29
00673693063791EprediaMicrotome Knife, 25 CM, D1520902024-10-29
00673693063807EprediaMicrotome Knife, 30 CM, D1521002024-10-29
00673693063814EprediaTungsten Carbide Knife, 16 CM1521202024-10-29
00673693064200EprediaAdamas Blades for Disposable Magnetic Blade Carrie1600102024-10-29
00673693064231EprediaAdamas Blades for Disposable Magnetic Blade Carrie1600402024-10-29
00673693226707EprediaTungsten Carbide D-Profile Microtome Knives56010062024-10-29
00673693263177EprediaMicrotome Knife D-Profile 240 mm22220062024-10-29
00673693568074EprediaHistoPlast IM8331K2024-10-29
00673693220514EprediaMicrotome Knife C-Profile 240 mm22220052024-10-28
00673693232913EprediaStainless-Steel Microtome Knives 12.5 cm76192024-10-28
00673693233149EprediaStandard Microtome Knife 125 mm77022024-10-28
00673693233187EprediaStandard Microtome Knife 250 mm77042024-10-28
00673693233200EprediaStainless-Steel Microtome Knives 18.5 cm77192024-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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
00673693227513EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-10-08
00673693227520EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-10-08
00673693227537EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-10-08
00673693214254EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-08-02
00673693218368EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-08-02
00673693219310EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-08-02
00673693219327EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-08-02
00673693220460EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-08-02
00673693224147EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-08-02
00673693224154EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-08-02
00673693083751EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-08-01
00673693083768EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-08-01
00673693083775EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-08-01
00673693083782EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-08-01
00673693224116EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-08-01
00673693224123EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKER2024-08-01
00615233081735Tissue-Tek® Quick-Ray™SAKURA FINETEK U.S.A., INC.KER2020-03-17
00615233081797Tissue-Tek® Quick-Ray™SAKURA FINETEK U.S.A., INC.KER2020-03-17
00615233081803Tissue-Tek® Quick-Ray™SAKURA FINETEK U.S.A., INC.KER2020-03-17
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
10615233078770Cryomold®SAKURA FINETEK U.S.A., INC.KER2020-03-17
10615233078787Cryomold®SAKURA FINETEK U.S.A., INC.KER2020-03-17
00615233078346Tissue-Tek® NanoMold™SAKURA FINETEK U.S.A., INC.KER2020-01-27