FDA.reportPublic FDA data

NEO 900 HS MIOS 5

Primary DI
07640132987959
Brand
NEO 900 HS MIOS 5
Company
Haag-Streit AG
Model
HS MIOS 5
Published
2023-06-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NFFDevice, Storage, Images, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFFDevice, Storage, Images, OphthalmicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640132987959PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640132987959076401329879597640132987959

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical microscopeAn electrically-powered ophthalmic magnification instrument, usually stereoscopic, designed for use in the operating room (OR) to magnify structures within the eye or its surroundings, and/or provide slit-lamp functionality to delineate intraocular structures or defects, during ophthalmic surgical procedures. It can be fixed or mobile (on wheels) and is typically equipped with motorized controls (foot-switch) for adjusting focus, magnification [zoom], illumination, and position, and with articulating arms; some types have integrated video cameras along with digital imaging and user interface screens.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
483467544
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
07640132988956Metis 900400201040020102025-02-06
07640132987935HS Hi-R NEO 900 MicroscopeHS Hi-R NEO 9002023-06-13
07640132987942HS Hi-R NEO 900 MicroscopeHS Hi-R NEO 900A2023-06-13
07640132988017HS NEO 900 CarrierFS 2-252023-06-13
07640132985610Imaging SetBI 90072205352022-11-22
07640132986549HeadrestWith Lower Part10215542022-11-22
07640132986556HeadrestWith Lower Part RAL 703514201812022-11-22
07640132986563HeadrestWith Lower Part Silver14201822022-11-22
07640132986570HeadrestWith Lower Part RAL 900514201832022-11-22
07640132986600HeadrestWith Lower Part Silver14201862022-11-22
07640132986617HeadrestWith Lower Part for RAL 703514201872022-11-22
07640132986655HeadrestWith Lower Part for adapter RAL 703514201912022-11-22
07640132986679HeadrestFor Pendulum Table RAL 703514201932022-11-22
07640132986686HeadrestFor Pendulum Table Silver14201942022-11-22
07640132986747HeadrestWith Lower Part for adapter RAL 703514202002022-11-22
07640132986754HeadrestWithout lower Silver14202012022-11-22
07640132986761HeadrestWithout lower RAL 703514202022022-11-22
07640132986778HeadrestWithout lower Silver14202032022-11-22
07640132986785HeadrestWithout lower RAL 703514202042022-11-22
07640132986792HeadrestWithout lower Silver14202052022-11-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260284390013Navilas® Laser System 577sOD-OS GmbHNFF2023-11-21
04987669200636Image filing software NAVIS-EXNIDEK CO.,LTD.NFF2023-06-12
04549292182729CANON INC.CANON INC.NFF2020-10-16
00380659982699VERION™Alcon Laboratories, Inc.NFF2020-08-31
00380659982705VERION™Alcon Laboratories, Inc.NFF2020-08-31
00380659982811VERION™Alcon Laboratories, Inc.NFF2020-08-31
04987669100523Image filing softwareNIDEK CO.,LTD.NFF2016-08-26
04987669100554NON-MYDRIATIC AUTO FUNDUS CAMERANIDEK CO.,LTD.NFF2016-06-24
04049471094077VISUPAC 500Carl Zeiss Meditec AGNFF2016-01-15