FDA.reportPublic FDA data

Epredia

Primary DI
00810041337726
Brand
Epredia
Company
NEW ERIE SCIENTIFIC LLC
Model
Cover Slips
Catalog number
BB02400360AC13MNZ0
Published
2025-03-13
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
KESCoverslips, Microscope Slide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KESCoverslips, Microscope SlidePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810041337726PrimaryGS10
10810041337723Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810041337726008100413377268100413377260810041337726
1081004133772310810041337723

GMDN Terms#

Term, Definition table
TermDefinition
Microscope slide coverslip IVDA thin piece of glass or a plastic sheath placed over a specimen on a microscope slide, to serve as a physical barrier to protect the specimen from mechanical forces and environmental exposure. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
361605223
Device count
1000
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
00850040101652Epredia LS-4041I-8524-1CESlideMate Laser Microscope Slides White tab2025-10-22
00850040101669Epredia LS-5041I-8524-1CESlideMate Laser Microscope Slides Blue tab2025-10-22
00850040101676Epredia LS-6041I-8524-1CESlideMate Laser Microscope Slides Green tab2025-10-22
00850040101683EprediaLS-7041I-8524-1CESlideMate Laser Microscope Slides Pink tab2025-10-22
00850040101690EprediaLS-8041I-8524-1CESlideMate Laser Microscope Slides Yellow tab2025-10-22
00850040101706Epredia LS-4041IPS8523-1CESlideMate Laser Plus Microscope Slides White tab2025-10-22
00850040101713Epredia LS-5041IPS8523-1CESlideMate Laser Plus Microscope Slides Blue tab2025-10-22
00850040101720Epredia LS-6041IPS8523-1CESlideMate Laser Plus Microscope Slides Green tab2025-10-22
00850040101737Epredia LS-7041IPS8523-1CESlideMate Laser Plus Microscope Slides Pink tab2025-10-22
00850040101744Epredia LS-8041IPS8523-1CESlideMate Laser Plus Microscope Slides Yellow tab2025-10-22
00850040101751Epredia LS-4041I-4-8560CSlideMate Laser Slides (Non-Adhesion), White Tab 22025-10-22
00850040101768Epredia LS-5041I-4-8560CSlideMate Laser Slides (Non-Adhesion), Blue Tab 252025-10-22
00850040101775Epredia LS-6041I-4-8560CSlideMate Laser Slides (Non-Adhesion), Green Tab 22025-10-22
00850040101782Epredia LS-7041I-4-8560CSlideMate Laser Slides (Non-Adhesion), Pink Tab 252025-10-22
00850040101799Epredia LS-8041I-4-8560CSlideMate Laser Slides (Non-Adhesion), Yellow Tab 2025-10-22
00810041333988Epredia Cover SlipsBB02400500P113MNZ12025-06-26
10810041333985Epredia Cover SlipsBB02400500P113MNZ12025-06-26
00810041333308Epredia BC05000760A140MNZ02025-03-17
00810041333032Epredia Cover SlipsBC06601000A140MNZ12025-03-17
00810041333049Epredia Cover SlipsBC02200250A133AUT02025-03-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00612479135475McKessonMCKESSON MEDICAL-SURGICAL INC.KES2026-03-11
00612479135505McKessonMCKESSON MEDICAL-SURGICAL INC.KES2026-03-11
00612479160415McKessonMCKESSON MEDICAL-SURGICAL INC.KES2026-03-11
00612479160422McKessonMCKESSON MEDICAL-SURGICAL INC.KES2026-03-11
10194484321557N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KES2025-08-09
10194484321281N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KES2025-08-08
10194484321298N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KES2025-08-08
20849832016001Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832016018Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832016025Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832016032Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832016049Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832017640Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832017701Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832017756Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832017763Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832017794Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832022705Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832022736Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832023207Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832023351Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832023368Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832025645Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
00810041333988Epredia NEW ERIE SCIENTIFIC LLCKES2025-06-26
10849832013454Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-06-04
00810041333308Epredia NEW ERIE SCIENTIFIC LLCKES2025-03-17
04064279008088Marienfeld SuperiorPaul Marienfeld GmbH & Co. KGKES2024-04-26
04064279008262Marienfeld SuperiorPaul Marienfeld GmbH & Co. KGKES2024-04-26
04064279008637Marienfeld SuperiorPaul Marienfeld GmbH & Co. KGKES2024-04-26
04064279008682Marienfeld SuperiorPaul Marienfeld GmbH & Co. KGKES2024-04-26