FDA.reportPublic FDA data

Zeiss Stemi 508

Primary DI
04064897000006
Brand
Zeiss Stemi 508
Company
Carl Zeiss Microscopy GmbH
Model
Stemi 508 body
Catalog number
435064-9000-000
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
04064897000006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04064897000006040648970000064064897000006

GMDN Terms#

Term, Definition table
TermDefinition
Stereo light microscopeA magnification instrument designed with a standard microscope configuration with the object viewed through two observation objectives and oculars from above to provide a three-dimensional (3-D) view of the object under low magnification by transmitted light (typically no more than 60x). It is used in laboratories and for research, particularly for dissection, and 3-D viewing of large or living specimens. It 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
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
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
04064897000068Zeiss Axio ObserverAxio Observer 3431004-9901-0002022-09-28
04064897000075Zeiss Axio ObserverAxio Observer 5431006-9901-0002022-09-28
04064897000082Zeiss Axio ObserverAxio Observer 7431007-9904-0002022-09-28

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
06909262200309ZEISS 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