FDA.report

Epredia

Primary DI
00810041336903
Brand
Epredia
Company
NEW ERIE SCIENTIFIC LLC
Model
Microscope Slide Non Adhesion
Catalog number
AF00008032E04MNZ20
Published
2025-03-05
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
KEWSlides, Microscope

Product Code Classifications

CodeDeviceSpecialtyClass
KEWSlides, MicroscopePathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810041336903PrimaryGS10
10810041336900Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810041336903008100413369038100413369030810041336903
1081004133690010810041336900

GMDN Terms

TermDefinition
General specimen microscopy slide IVD, single-useA glass or plastic microscopy slide intended to be used for the collection, and preservation and/or transport, of any type of clinical specimen or smear for analysis and/or other investigation. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
361605223
Device count
72
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

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