FDA.reportPublic FDA data

Epredia

Primary DI
00673693214995
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Premium High Profile Microtome Blades
Catalog number
1001259
Device description
The blades and knifes consumables are for use with microtomes and cryostats. Microtomes and cryostats are devices used to produce consistent thickness slices of tissue samples, they are then mounted on glass slides, stained and typically examined by microscopy. Microtomes for light microscopy typically use disposable blades, to maintain the quality of the cut and thus the section quality. Therefore they must be changed regularly. The frequency of changing depends on the number of sections cut, hardness of the tissue and appropriate use.
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

Product Codes#

Code, Name table
CodeName
IDLMicrotome, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IDLMicrotome, AccessoriesPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673693214995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693214995006736932149956736932149950673693214995

GMDN Terms#

Term, Definition table
TermDefinition
Microtome blade IVD, single-useA flat, wedge-shaped, sharp blade intended to be mounted into a microtome to cut micro-thin slices of tissue that has been fixed, and usually impregnated, with paraffin wax. The resulting sections are mounted onto slides for staining and then viewing with a microscope. 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
10843382103979AccuThrive®AccuTec, Inc.IDL2024-12-17
10843382104006AccuThrive®AccuTec, Inc.IDL2024-12-17
10843382104013AccuThrive®AccuTec, Inc.IDL2024-12-17
10843382104020AccuThrive®AccuTec, Inc.IDL2024-12-17
10843382104037AccuThrive®AccuTec, Inc.IDL2024-12-17
10843382104044AccuThrive®AccuTec, Inc.IDL2024-12-17
10843382104051AccuThrive®AccuTec, Inc.IDL2024-12-17
10843382104068AccuThrive®AccuTec, Inc.IDL2024-12-17
10843382104075AccuThrive®AccuTec, Inc.IDL2024-12-17
10843382104082AccuThrive®AccuTec, Inc.IDL2024-12-17
10843382104280AccuThrive®AccuTec, Inc.IDL2024-12-17
10843382104297AccuThrive®AccuTec, Inc.IDL2024-12-17
00673693063494EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIDL2024-10-29
00673693063500EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIDL2024-10-29
00673693063753EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIDL2024-10-29
00673693063760EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIDL2024-10-29
00673693063777EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIDL2024-10-29
00673693063784EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIDL2024-10-29
00673693063791EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIDL2024-10-29
00673693063807EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIDL2024-10-29
00673693063814EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIDL2024-10-29
00673693064200EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIDL2024-10-29
00673693064231EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIDL2024-10-29
00673693226707EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIDL2024-10-29
00673693263177EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIDL2024-10-29
00673693220514EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIDL2024-10-28
00673693232913EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIDL2024-10-28
00673693233149EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIDL2024-10-28
00673693233187EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIDL2024-10-28
00673693233200EprediaRICHARD-ALLAN SCIENTIFIC COMPANYIDL2024-10-28