FDA.reportPublic FDA data

CELLPRESERV KOLPLAST

Primary DI
07898027907630
Brand
CELLPRESERV KOLPLAST
Company
Kolplast C I
Model
CELLPRESERV CYTOCENTRIFUGE
Catalog number
10.1315
Published
2023-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IFBCytocentrifuge

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IFBCytocentrifugePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898027907630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898027907630078980279076307898027907630

GMDN Terms#

Term, Definition table
TermDefinition
Cytological centrifuge IVDAn electrically-powered device intended to be used in a clinical laboratory setting to separate the cellular components of suspensions in a clinical specimen through centrifugal force for subsequent cytological analysis. It is typically a compact unit with an electric motor, a vertical shaft, and a special horizontal rotor attached that enables cells to be separated from a liquid suspension and deposited directly onto a microscope slide for microscopic examination.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
903963889
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07898027905902KOLPLASTStandard2019-09-13
07898027900792CELLPRESERV KOLPLASTFILTRO GIN CELLPRESERV10.13472023-11-29
07898027901355KOLPLASTRETOSIGMOIDOSCOPIO10.13822023-11-29
07898027902130VAGISPEC KOLPLASTESPEC VAG VAGISPEC G LUB E9007009232023-11-29
07898027902154VAGISPEC KOLPLASTESPEC VAG KOLPLAST G LONGO10.13292023-11-29
07898027902161VAGISPEC KOLPLASTESPEC VAG KOLPLAST G LONGO EST10.13302023-11-29
07898027903038VAGISPEC KOLPLASTESPECULO VAG KOLPLAST VIRGEM EKPV2023-11-29
07898027903311KOLPLASTRETOSIGMOIDOSCOPIORETO2023-11-29
07898027903656VAGISPEC KOLPLASTESPEC VAG VAGISPEC P NLUB E9001009212023-11-29
07898027903663VAGISPEC KOLPLASTESPEC VAG VAGISPEC P E LUB9001009232023-11-29
07898027903687VAGISPEC KOLPLASTESPEC VAG VAGISPEC G E NLUB9007009212023-11-29
07898027904110VAGISPEC KOLPLASTESPECULO VAG KOLPLAST M E9054009212023-11-29
07898027904127VAGISPEC KOLPLASTESPEC VAG VAGISPEC M E LUB9054009232023-11-29
07898027905353KOLPLASTSWAB HASTE REGULAR D2,5 FP EST10.41092023-11-29
07898027905490CELLPRESERV KOLPLASTCELLPRESERV GLASS SLIDE4001010982023-11-29
07898027905988VAGISPEC KOLPLASTESPECULO VAG KOLPLAST P NE9001002102023-11-29
07898027906015VAGISPEC KOLPLASTESPECULO VAG KOLPLAST M NE9054002102023-11-29
07898027906312VAGISPEC KOLPLASTESPECULO VAG KOLPLAST G NE9007002102023-11-29
07898027907074VAGISPEC KOLPLASTESPEC VAG KOLP M KOLPLUX NE10.10382023-11-29
07898027907159VAGISPEC KOLPLASTESPEC VAG KOLP M KOLPLUX NE 2510.12022023-11-29

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