FDA.reportPublic FDA data

ZEISS Axiolab

Primary DI
06909262200231
Brand
ZEISS Axiolab
Company
Carl Zeiss Suzhou Co., Ltd.
Model
Axiolab 5
Catalog number
430037-9011-000
Published
2021-01-01
Public version status
New
Distribution status
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
06909262200231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06909262200231069092622002316909262200231

GMDN Terms#

Term, Definition table
TermDefinition
Basic light microscopeA magnification instrument designed with a standard microscope configuration [the object viewed through an ocular(s) from above] used to magnify and study specimens and small objects by transmitted visible light. It is widely used in laboratories and for research and in healthcare facilities where there is a need for such magnification. The device consists of a stand that supports the main components, an ocular body in which the eyepieces are mounted, a nosepiece to support the objectives, a specimen stage, a condenser to focus the light on the specimen, and a source of light [e.g., tungsten (W), halogen] and light port.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-40 Degrees Celsius70 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
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
528182577
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
06909262200156Zeiss AxiovertAxiovert 5431030-9050-0002026-05-19
06909262061375OPMI® LUMERA® 30061372022-08-11
06909262060330EXTARO® 30060332022-08-11
06909262060347EXTARO® 30060342022-08-11
06909262060354EXTARO® 30060352022-08-11
06909262100104EXTARO® 300000000-2327-7552022-08-11
06909262200040ZEISS Axio VertAxio Vert.A1431030-9000-0002021-01-01
06909262200057ZEISS Axio VertAxio Vert.A1431030-9010-0002021-01-01
06909262200064ZEISS Axio VertAxio Vert.A1431030-9040-0002021-01-01
06909262200118ZEISS Axio LabAxio Lab.A1430037-9010-0002021-01-01
06909262200125ZEISS Axio LabAxio Lab.A1430037-9020-0002021-01-01
06909262200248ZEISS AxiolabAxiolab 5430037-9021-0002021-01-01
06909262200286ZEISS AxiolabAxiolab 5430037-9060-0002021-01-01
06909262200293ZEISS AxiolabAxiolab 5430037-9070-0002021-01-01
06909262200316ZEISS Axio LabAxio Lab.A1430037-9000-0002021-01-01
06909262200323ZEISS AxioscopeAxioscope 5430035-9032-0002021-01-01
06909262200330ZEISS AxioscopeAxioscope 5430035-9061-0002021-01-01
06909262200378ZEISS AxioscopeAxioscope 5430035-9201-0002021-01-01
06909262200422ZEISS AxioscopeAxioscope 5430035-9261-0002021-01-01
06909262200460ZEISS AxiolabAxiolab 5430037-9110-0002021-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06909262200156Zeiss AxiovertCarl Zeiss Suzhou Co., Ltd.MTX2026-05-19
00664816005316LW Scientific, Inc.LW SCIENTIFIC, INC.MTX2026-04-17
00664816005323LW Scientific, Inc.LW SCIENTIFIC, INC.MTX2026-04-17
04582754071520IX73 2PORT FRAMEEVIDENT CORPORATIONMTX2025-10-31
04582754071674TRANSMITTED ILLUMINATOREVIDENT CORPORATIONMTX2025-10-31
04582754073340CONTROL BOX MEVIDENT CORPORATIONMTX2025-10-31
04582754073357HAND SWITCHEVIDENT CORPORATIONMTX2025-10-31
04582754073364LED POWER SUPPLYEVIDENT CORPORATIONMTX2025-10-31
04582754073371EYEPIECEEVIDENT CORPORATIONMTX2025-10-31
04582754073388EYEPIECEEVIDENT CORPORATIONMTX2025-10-31
04582754073609UNIVERSAL PLAN SEMI-APOCHROMATIC OBJECTIVE LENSEVIDENT CORPORATIONMTX2025-10-31
04582754073838UNIVERSAL PLAN SEMI-APOCHROMATIC OBJECTIVE LENSEVIDENT CORPORATIONMTX2025-10-31
04582754074095UIS2 OBJECTIVE LENS FOR BIOLOGYEVIDENT CORPORATIONMTX2025-10-31
06975183900185Harioculture TL-16 Time-lapse IncubatorHua Yue Medical Technology Co., Ltd.MTX2025-09-30
06975183900192Time-lapse Incubator Capacity Expansion ModuleHua Yue Medical Technology Co., Ltd.MTX2025-09-30
04582754070608100W HALOGEN LAMP HOUSINGEVIDENT CORPORATIONMTX2025-07-25
04582754070639EXTENSION CORDEVIDENT CORPORATIONMTX2025-07-25
04549921600341ECLIPSE Ti2-I USNIKON CORPORATIONMTX2025-07-01
06975737430120MetiecWuhan Huchuang Union Technology Co., Ltd.MTX2024-05-27
04582643159520UNIVERSAL PLAN SEMI-APOCHROMATIC OBJECTIVE LENSEVIDENT CORPORATIONMTX2024-05-10
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
04064897000068Zeiss Axio ObserverCarl Zeiss Microscopy GmbHMTX2022-09-28
04064897000075Zeiss Axio ObserverCarl Zeiss Microscopy GmbHMTX2022-09-28
04064897000082Zeiss Axio ObserverCarl Zeiss Microscopy GmbHMTX2022-09-28