FDA.reportPublic FDA data

Leica CV5030-TS5025

Primary DI
04049188001887
Brand
Leica CV5030-TS5025
Company
Leica Biosystems Nussloch GmbH
Model
149CVTS5025
Catalog number
149CVTS5025
Device description
The Leica CV5030 is a robotic coverslipper for coverslipping tissue sections, cells or swabs mounted on specimen slides with cover slips made out of glass using a wide variety of differ¬ent cover slip mountants. It may only be used with instrument accessories approved by Leica Biosystems Nussloch GmbH.
Published
2018-11-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KIMDEVICE FOR SEALING MICROSECTIONS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIMDevice For Sealing MicrosectionsPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049188001887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049188001887040491880018874049188001887

GMDN Terms#

Term, Definition table
TermDefinition
Microscope slide coverslipA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4962241430CHS.support@LeicaBiosystems.co
+4962241430CHS.support@LeicaBiosystems.com

Regulatory Flags#

DUNS number
315539452
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049188210777ASP6025 S 230V/50-60Hz000000014049559058140495590582019-07-05
04049188210784ASP6025 S 120V/50-60Hz000000014049559068140495590682019-07-05
04049188210791ASP6025 S China000000014049559088140495590882019-07-05
04049188216397HistoCore PEGASUS000000014048858005140488580052021-11-02
04049188217769HistoCore PEGASUS Plus000000014048858007140488580072021-11-02
04049188003102Leica TP1020 VF/accessories1491020US021491020US022018-12-04
04049188003119Leica TP1020 F /accessories1491020US011491020US012018-12-04
04049188055903Basket set Leica ASP300 S000000014047643576140476435762018-12-04
04049188055965Leica ASP300 S000000014047643515140476435152018-12-04
04049188055972Leica ASP300 S - 230-240V000000014047643514140476435142018-12-04
04049188056146Leica ASP300 S - China000000014047643057140476430572018-12-04
04049188057334Basket, assy., large000000014047634782140476347822018-12-04
04049188058423Basket000000014047634194140476341942018-12-04
04049188087706Leica TP1020 with Chloroform000000014042242238140422422382018-11-16
04049188087843Tissue basket - Cone000000014042232564140422325642018-12-04
04049188087973Flexible tube 50x4000000000014042231975140422319752018-12-04
04049188087980Flexible tube 50x2000000000014042231974140422319742018-12-04
04049188088246Leica TP1020 (Double loading) Without vaccum/w000000014042231418140422314182018-11-16
04049188088253Leica TP1020 (Double loading) With fume control000000014042231416140422314162018-11-16
04049188088260Leica TP1020 (Double loading) With vacuum/ without fume control000000014042231414140422314142018-11-16

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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