Epredia

Primary DI
00673693181846
Brand
Epredia
Company
RICHARD-ALLAN SCIENTIFIC COMPANY
Model
Mark-It™ Tissue Marking Dye Kit
Catalog number
5000
Device description
Tissue Marking Dyes are intended as an aid in the orientation, of excised surgical specimens through frozen sectioning, processing, and sectioning, and subsequent microscopic examination of tissues. The marking of multiple margins with these dyes is especially useful for identification in skin biopsies, a technique known as Moh’s surgery. These dyes are normally applied to fresh tissue but may also be used with fixed tissue. Whether fresh or fixed, the tissue should be blotted to remove excess fluid from the surface before applying the dye. Tissue Marking Dyes will permanently bond to the tissue 1 to 2 minutes after application. The tissue can then be frozen and prepared for sectioning or placed in formalin or other fixatives and processed for paraffin embedding.
Published
2024-08-06
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
LEEStains, Dye Solution

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LEEStains, Dye SolutionHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00673693181846PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00673693181846006736931818466736931818460673693181846

GMDN Terms#

Term, Definition table
TermDefinition
Biopsy tissue marking dye applicator IVDA device intended to apply marking dye on a tissue biopsy specimen. It is in the form of a stick and is typically made of wood or plastic materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
929504710
Device count
1
Premarket exempt
true
Kit
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
00849832013471Leica BiosystemsLeica Biosystems Richmond, Inc.LEE2025-04-22
00849832020523Leica BiosystemsLeica Biosystems Richmond, Inc.LEE2025-04-17
00849832021247Leica BiosystemsLeica Biosystems Richmond, Inc.LEE2025-04-17
00849832021308Leica BiosystemsLeica Biosystems Richmond, Inc.LEE2025-04-17
00849832027034Leica BiosystemsLeica Biosystems Richmond, Inc.LEE2025-04-17
00849832013464Leica BiosystemsLeica Biosystems Richmond, Inc.LEE2024-12-19
00673693089661EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-09-06
00673693089906EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-09-06
00673693202251EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-09-06
00673693202282EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-09-06
00673693202305EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-09-06
00673693089487EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-09-05
00673693235730EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-09-04
00673693089388EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-27
00673693089401EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-27
00673693089425EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-27
00673693089463EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-27
00673693169004EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-27
00673693202145EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-23
00673693202121EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-12
00673693089302EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-09
00673693181891EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-06
00673693181907EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-06
00673693181914EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-06
00673693181921EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-06
00673693181938EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-06
00673693181945EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-06
00673693222181EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-06
00673693222198EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-06
00673693222204EprediaRICHARD-ALLAN SCIENTIFIC COMPANYLEE2024-08-06