FDA.reportPublic FDA data

Epredia

Primary DI
05051663626071
Brand
Epredia
Company
SHANDON DIAGNOSTICS LIMITED
Model
Laser Embedding Cassettes - White
Catalog number
110-01-10LMI
Device description
Stripped stacks, 25x40mm
Published
2026-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
IDZCassettes, Tissue

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IDZCassettes, TissuePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05051663626071PrimaryGS10
05051663626927Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05051663626071050516636260715051663626071
05051663626927050516636269275051663626927

GMDN Terms#

Term, Definition table
TermDefinition
Histology tissue cassette IVD, laboratory processing, single-useA small device intended to be used in the laboratory to support/contain clinical tissue specimens (e.g., biopsy samples) to facilitate specimen processing [e.g., fixation (encapsulation in paraffin wax), dehydration, infiltration] in preparation for subsequent cytological or histological examination, and storage. It is in the form of a plastic container, with or without a lid, with drainage holes to maximize fluid exposure during tissue submersion in a parent device into which the container is loaded. It may, in addition, include a fenestrated insert to hold and prevent the loss of a smaller specimens. This is a single-use device.

Regulatory Flags#

DUNS number
219103512
Device count
1000
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05051663626927EprediaLaser Embedding Cassettes - White110-01-10LMI2026-03-11
05051663011501EprediaAvantik QS12 Cryostat-UK956660-UK2025-11-07
05051663011518EprediaAvantik QS12 UV Cryostat-UK956661-UK2025-11-07
05051663011112EprediaHM525 NX Cryostat-UK956640-UK 2025-08-26
05051663011129EprediaHM525 NX UV Cryostat-UK956641-UK2025-08-26
05051663010580EprediaHM 355S Rotary Microtome-UK905200-UK2025-06-11
05051663010467EprediaE1000 Dx Digital Pathology Solution A85200002 2025-03-10
05051663518581EprediaRevos Chamber Filter Assembly KitA841101552024-06-13
05051663518598EprediaChamber Filter Tool KitA841101562024-06-13
05051663518604EprediaNose Cone Extraction Tool KitA841101572024-06-13
05051663010528EprediaHM 325 Rotary Microtome (UK made)902100-UK2024-05-10
05051663010559EprediaHM 340E Rotary Microtome (UK made)905190-UK 2024-05-10
05051663517362EprediaSLIP HOPPER 24x40mm #1.5A792100502024-02-16
05051663517379EprediaSLIP HOPPER 24x50mm #1.5A792100512024-02-16
05051663517386EprediaSLIP HOPPER 24x55mm #1.5A792100522024-02-16
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810050855904Embedding CassetteTYPENEX MEDICAL LLCIDZ2026-05-14
10810050855911Embedding CassetteTYPENEX MEDICAL LLCIDZ2026-05-14
10810050855928Embedding CassetteTYPENEX MEDICAL LLCIDZ2026-05-14
10810050855935Embedding CassetteTYPENEX MEDICAL LLCIDZ2026-05-14
20849832018302Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2026-04-30
10194484321663N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
10194484321670N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
10194484321687N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
10194484321694N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
10194484321700N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
10194484321717N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
10194484321755N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-11
10194484321212N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
10194484321229N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
10194484321359N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
10194484321366N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
10194484321373N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
10194484321380N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
10194484321397N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
10194484321403N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.IDZ2025-08-08
10849832001000Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
10849832001017Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
10849832001024Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
10849832001031Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
10849832001048Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
10849832001055Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
10849832003097Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
10849832025815Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
10849832025822Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23
10849832025839Leica BiosystemsLeica Biosystems Richmond, Inc.IDZ2025-07-23