FDA.reportPublic FDA data

Zeiss Axio Observer

Primary DI
04064897000068
Brand
Zeiss Axio Observer
Company
Carl Zeiss Microscopy GmbH
Model
Axio Observer 3
Catalog number
431004-9901-000
Published
2022-09-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MTXMicroscope and microscope accessories, reproduction, assisted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MTXMicroscope And Microscope Accessories, Reproduction, AssistedObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04064897000068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04064897000068040648970000684064897000068

GMDN Terms#

Term, Definition table
TermDefinition
Inverted-stage light microscopeA magnification instrument designed with illumination placed at the top with the stage (the specimen platform) below, and the optics on the bottom for microscopic study of large specimens by transmitted light. It is typically used in the laboratory for investigation and research. The device consists of a stand that supports the main components, an ocular body in which the eyepieces are mounted, a specimen stage, a condenser to focus the light on the specimen, and a source of light. It is typically used for the examination of tissue cultures in all types of culture vessels (e.g., Petri dishes, culture bottles) and also in microtest and microtitre plates.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+493641644020udi.microscopy@zeiss.com

Regulatory Flags#

DUNS number
537598935
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
04064897000006Zeiss Stemi 508Stemi 508 body435064-9000-0002022-09-28
04064897000013Zeiss Stemi 508Stemi 508 doc body435064-9020-0002022-09-28
04064897000020Zeiss Stemi 508Stemi 508 trino body435064-9030-0002022-09-28
04064897000037Zeiss SteREO DiscoverySteREO Discovery.V8435000-0000-0002022-09-28
04064897000044Zeiss SteREO DiscoverySteREO Discovery.V12435001-9901-0002022-09-28
04064897000051Zeiss SteREO DiscoverySteREO Discovery V20435003-9901-0002022-09-28
04064897000075Zeiss Axio ObserverAxio Observer 5431006-9901-0002022-09-28
04064897000082Zeiss Axio ObserverAxio Observer 7431007-9904-0002022-09-28

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Primary DI, Brand, Company table
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06975737430120MetiecWuhan Huchuang Union Technology Co., Ltd.MTX2024-05-27
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04582643149095UNIVERSAL PLAN SEMI-APOCHROMATIC OBJECTIVE LENSEVIDENT CORPORATIONMTX2023-07-31
04064897000006Zeiss Stemi 508Carl Zeiss Microscopy GmbHMTX2022-09-28
04064897000013Zeiss Stemi 508Carl Zeiss Microscopy GmbHMTX2022-09-28
04064897000020Zeiss Stemi 508Carl Zeiss Microscopy GmbHMTX2022-09-28
04064897000037Zeiss SteREO DiscoveryCarl Zeiss Microscopy GmbHMTX2022-09-28
04064897000044Zeiss SteREO DiscoveryCarl Zeiss Microscopy GmbHMTX2022-09-28
04064897000051Zeiss SteREO DiscoveryCarl Zeiss Microscopy GmbHMTX2022-09-28
04064897000075Zeiss Axio ObserverCarl Zeiss Microscopy GmbHMTX2022-09-28
04064897000082Zeiss Axio ObserverCarl Zeiss Microscopy GmbHMTX2022-09-28
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