FDA.reportPublic FDA data

Epredia

Primary DI
00673693089029
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Paraffin, Type 9
Catalog number
8337
Device description
The Paraffin line is specially designed for tissue processing and embedding of histological and cytological specimens. The product is a white solid at room temperature and a clear, liquid when molten. The paraffin can be used with both open and closed tissue processors. It is also compatible with all embedding centers and manual embedding techniques. Paraffin is used in tissue processing during the infiltration steps. Melting points and polymer content differ between formulations. Choosing which type of paraffin may depend on the tissue density or personal preference of the histotechnician. Softer kinds of paraffin with less polymer tend to infiltrate tissue slightly quicker during processing but yield a softer block during embedding. Softer kinds of paraffin better lend themselves to thicker sections during microtomy. Harder kinds of paraffin with a higher polymer content usually take a little more time to infiltrate the tissue during processing but yield harder blocks that allow thinner sectioning during microtomy. Harder tissue specimens are better supported with a harder paraffin block.
Published
2024-08-14
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
KEOFormulations, Paraffin, All

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KEOFormulations, Paraffin, AllPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673693089029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693089029006736930890296736930890290673693089029

GMDN Terms#

Term, Definition table
TermDefinition
Paraffin-based embedding medium IVDA paraffin-based embedding material intended to be used as an embedding medium in the processing of biological tissues or clinical specimens.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
929504710
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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
10849832000973Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2025-02-03
10849832021664Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2025-02-03
00849832000976Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2025-02-03
00849832021667Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2025-02-03
10849832012525Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-19
10849832012532Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-19
10849832020476Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-19
00849832012528Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-19
00849832012535Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-19
00849832020479Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-19
10849832000942Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-18
10849832000966Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-18
10849832012549Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-18
10849832012563Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-18
10849832012570Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-18
10849832021626Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-18
10849832021640Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-18
00849832000945Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-18
00849832000969Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-18
00849832012542Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-18
00849832012566Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-18
00849832012573Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-18
00849832000938Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-18
00849832021643Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-18
10849832021428Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-15
10849832021435Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-15
00849832021421Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-15
00849832021438Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-15
00673693568074EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEO2024-10-29
00673693088992EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEO2024-08-07