FDA.reportPublic FDA data

Epredia

Primary DI
10810041333985
Brand
Epredia
Company
NEW ERIE SCIENTIFIC LLC
Model
Cover Slips
Catalog number
BB02400500P113MNZ1
Published
2025-06-26
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
KESCoverslips, Microscope Slide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KESCoverslips, Microscope SlidePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810041333988PrimaryGS10
10810041333985Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810041333988008100413339888100413339880810041333988
1081004133398510810041333985

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
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
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
00810041333308Epredia BC05000760A140MNZ02025-03-17
00810041333032Epredia Cover SlipsBC06601000A140MNZ12025-03-17
00810041333049Epredia Cover SlipsBC02200250A133AUT02025-03-17
00810041333056Epredia Cover SlipsBC02200250A133MNZ02025-03-17

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