FDA.report

Epredia

Primary DI
00810041336965
Brand
Epredia
Company
NEW ERIE SCIENTIFIC LLC
Model
Cover Slips
Catalog number
BB02400550SC13MNZ0
Published
2025-03-11
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

Related Records

Product Codes

CodeName
KESCoverslips, Microscope Slide

Product Code Classifications

CodeDeviceSpecialtyClass
KESCoverslips, Microscope SlidePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810041336965PrimaryGS10
10810041336962Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810041336965008100413369658100413369650810041336965
1081004133696210810041336962

GMDN Terms

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

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 DIBrandModelCatalogPublished
10810041333985Epredia Cover SlipsBB02400500P113MNZ12025-06-26
00810041333032Epredia Cover SlipsBC06601000A140MNZ12025-03-17
00810041333049Epredia Cover SlipsBC02200250A133AUT02025-03-17
00810041333056Epredia Cover SlipsBC02200250A133MNZ02025-03-17
00810041333063Epredia Cover SlipsBC02200260A233MNZ02025-03-17
00810041333070Epredia Cover GlassBC02200300A113MNZ02025-03-17
00810041333087Epredia Cover SlipsBC02200440A233MNZ02025-03-17
00810041333094Epredia Cover SlipsBC02200490AC13MNZ02025-03-17
00810041333117Epredia Cover SlipsBC02200710A140MNZ02025-03-17
00810041333124Epredia Cover SlipsBC02400440A113MNZ02025-03-17
00810041333131Epredia Cover SlipsBC02400650AC33MNZ02025-03-17
00810041333148Epredia Cover GlassBC02400730A140MNZ02025-03-17
00810041333155Epredia Cover SlipsBC02400740A140MNZ02025-03-17
00810041333162Epredia Cover SlipsBC02400740AC40MNZ02025-03-17
00810041333179Epredia Cover SlipsBC02400750A140MNZ02025-03-17
00810041333186Epredia Cover SlipsBC02500250A233MNZ02025-03-17
00810041333193Epredia Cover SlipsBC02500550A113MNZ02025-03-17
00810041333209Epredia Cover SlipsBC02500750A240MNZ02025-03-17
00810041333216Epredia Cover SlipsBC03500550AC40MNZ02025-03-17
00810041333223Epredia Cover SlipsBC04800640A140MNZ02025-03-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00612479135468McKessonMCKESSON MEDICAL-SURGICAL INC.KES2026-03-11
00612479135512McKessonMCKESSON MEDICAL-SURGICAL INC.KES2026-03-11
00612479185388McKessonMCKESSON MEDICAL-SURGICAL INC.KES2026-03-11
00612479185395McKessonMCKESSON MEDICAL-SURGICAL INC.KES2026-03-11
06979203760285Chiwell BiotechnologyNingbo Chiwell Biotechnology Co., LtdKES2026-01-07
30194484321551N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KES2025-08-09
30194484321285N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KES2025-08-08
30194484321292N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KES2025-08-08
00849832016007Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
00849832016014Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
00849832016021Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
00849832016038Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
00849832016045Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
00849832017646Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
00849832017707Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
00849832017752Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
00849832017769Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
00849832017790Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
00849832022701Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
00849832022732Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
00849832023203Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
00849832023357Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
00849832023364Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
00849832025641Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
10810041333985Epredia NEW ERIE SCIENTIFIC LLCKES2025-06-26
00849832013457Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-06-04
00810041333032Epredia NEW ERIE SCIENTIFIC LLCKES2025-03-17
00810041333049Epredia NEW ERIE SCIENTIFIC LLCKES2025-03-17
00810041333056Epredia NEW ERIE SCIENTIFIC LLCKES2025-03-17
00810041333063Epredia NEW ERIE SCIENTIFIC LLCKES2025-03-17