FDA.reportPublic FDA data

Epredia

Primary DI
00673693168052
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Neg-50™ Colorless
Catalog number
6502
Device description
Neg-50™ is formulated to yield high-quality sections even down to -50°C without chatter and is available in blue, green, orange, pink, yellow and colorless.
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
KEQMedia, Mounting, Water Soluble

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KEQMedia, Mounting, Water SolublePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673693168052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693168052006736931680526736931680520673693168052

GMDN Terms#

Term, Definition table
TermDefinition
Tissue freezing/embedding medium IVDA tissue freezing and embedding material intended to be used as an embedding matrix for the preparation and processing of frozen sections from biological tissues or clinical specimens.

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
00849832001317Leica BiosystemsLeica Biosystems Richmond, Inc.KEQ2025-07-20
00849832012214Leica BiosystemsLeica Biosystems Richmond, Inc.KEQ2025-07-20
00849832012443Leica BiosystemsLeica Biosystems Richmond, Inc.KEQ2025-07-20
00673693168069EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693180733EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693180740EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693180757EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693180764EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693180771EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693180832EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693218511EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693228695EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693235969EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693235976EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693235990EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693236010EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693236027EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00810047420323N/AScientific Device Laboratory, Inc.KEQ2023-01-30
20613647023772FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KEQ2022-12-07
10615233078657Tissue-Tek®SAKURA FINETEK U.S.A., INC.KEQ2019-12-15