FDA.reportPublic FDA data

ZEISS Primostar 3

Primary DI
06909262200309
Brand
ZEISS Primostar 3
Company
Carl Zeiss Suzhou Co., Ltd.
Model
Primostar 3
Catalog number
415501-0031-001
Published
2026-07-23
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
false

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
06909262200309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06909262200309069092622003096909262200309

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.

Contacts#

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

Regulatory Flags#

DUNS number
528182577
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06909262200088Zeiss AxiovertAxiovert 5431030-9060-0002026-07-23
06909262200132Zeiss AxiovertAxiovert 5431030-9120-0002026-07-23
06909262200187ZEISS Primostar 3Primostar 3415501-0001-0002026-07-23
06909262200194ZEISS Primostar 3Primostar 3415501-0081-0002026-07-23
06909262200200ZEISS Primostar 3Primostar 3415501-0011-0002026-07-23
06909262200217ZEISS Primostar 3Primostar 3415501-0061-0002026-07-23
06909262200224ZEISS Primostar 3Primostar 3415501-0051-0002026-07-23
06909262200255ZEISS Primostar 3Primostar 3415501-0071-0002026-07-23
06909262200262ZEISS Primostar 3Primostar 3415501-0041-0002026-07-23
06909262200279ZEISS Primostar 3Primostar 3415501-0021-0012026-07-23
06909262200347ZEISS Primostar 3Primostar 3415501-0091-0002026-07-23
06909262200354ZEISS Primostar 3Primostar 3415501-0231-0002026-07-23
06909262200385ZEISS AxiolabAxiolab 5430037-9130-0002026-07-23
06909262200613Zeiss Primostar 1Primostar 1415501-0121-0002026-07-23
06909262200620ZEISS Primostar 1Primostar 1415501-0131-0002026-07-23
06909262200156Zeiss AxiovertAxiovert 5431030-9050-0002026-05-19
06909262061375OPMI® LUMERA® 30061372022-08-11
06909262060330EXTARO® 30060332022-08-11
06909262060347EXTARO® 30060342022-08-11
06909262060354EXTARO® 30060352022-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06909262200088Zeiss AxiovertCarl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200132Zeiss AxiovertCarl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200187ZEISS Primostar 3Carl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200194ZEISS Primostar 3Carl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200200ZEISS Primostar 3Carl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200217ZEISS Primostar 3Carl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200224ZEISS Primostar 3Carl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200255ZEISS Primostar 3Carl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200262ZEISS Primostar 3Carl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200279ZEISS Primostar 3Carl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200347ZEISS Primostar 3Carl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200354ZEISS Primostar 3Carl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200385ZEISS AxiolabCarl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200613Zeiss Primostar 1Carl Zeiss Suzhou Co., Ltd.MTX2026-07-23
06909262200620ZEISS Primostar 1Carl Zeiss Suzhou Co., Ltd.MTX2026-07-23
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