FDA.reportPublic FDA data

Epredia

Primary DI
00673693175470
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
10% Neutral Buffered Formalin Prefilled Container
Catalog number
LC-0090
Device description
10% Neutral Buffered Formalin Prefilled Containers were designed to provide safe, cost-effective transportation, storage, and retrieval of pathology specimens. Prefilled specimen containers are non-sterile clear containers with screw-top lids. Each container is prefilled with 10% Neutral Buffered Formalin which is the industry standard for tissue fixation. The 10% Neutral Buffered Formalin is the traditional formulation for phosphate-buffered formalin.Size and Quantity: 240 per case. 90 mL filled to 45 mL. Total: 10.8 Liters
Published
2024-07-19
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
IFPFormalin, Neutral Buffered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IFPFormalin, Neutral BufferedPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673693175470PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693175470006736931754706736931754700673693175470

GMDN Terms#

Term, Definition table
TermDefinition
Neutral buffered formalin IVDA neutral buffered formalin solution intended to be used as a fixative in the processing of biological tissues or clinical specimens. Some formulations may contain additional components such as zinc, alcohol, and/or eosin.

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
00613647018842FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647018859FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647018866FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647018873FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647018880FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647018897FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647027028FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647027035FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647027042FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647028353FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647028544FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647028575FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647028599FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
20613647018846FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
20613647018853FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
20613647018860FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
20613647018877FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
20613647018884FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
20613647018891FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
20613647027022FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
20613647027039FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
20613647027046FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
20613647028357FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647028360FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647028377FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647028384FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647028391FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647028407FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
20613647028548FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30
00613647028551FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.IFP2025-04-30