FDA.reportPublic FDA data

i.Terminal go

Primary DI
04250668607172
Brand
i.Terminal go
Company
Carl Zeiss Vision GmbH
Model
000000-2408-309
Catalog number
000000-2408-309
Device description
N/A
Published
2022-12-08
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
HMMDistometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMMDistometerOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250668607172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250668607172042506686071724250668607172

GMDN Terms#

Term, Definition table
TermDefinition
Vision corrective spectacles centration image analysis softwareAn application software program intended to be used to analyse images of a patient wearing spectacle frames to measure centration data (e.g., pupil position relative to frame, angle of frame relative to face) used to manufacture customized corrective spectacles.

Contacts#

Phone, Email table
PhoneEmail
+1(423)598-2680jahmal.cannon@zeiss.com

Regulatory Flags#

DUNS number
333928146
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250668607202VISUREF 600000000-2572-4242026-04-24
04250668607233ZEISS Mobile Centration000000-2750-321000000-2750-3212026-01-15
04250668606748VISU360000000-1011-377000000-1011-3772021-01-01
04250668606045VISUSCREEN 100 Compact000000-2522-536000000-2522-5362023-05-30
04250668606052VISUCORE 500 Refractor000000-2522-537000000-2522-5372023-05-30
04250668606618VISUCONSULT 500000000-2265-586000000-2265-5862021-01-01
04250668606649i.Terminal mobile000000-2120-340000000-2120-3402021-01-01
04250668606687VISUFIT 1000000000-2351-293000000-2351-2932021-01-01
04250668606700i.Terminal 2 Station000000-2433-519000000-2433-5192021-01-01
04250668606625i.Profiler plus000000-1005-825000000-1005-8252021-01-01
04250668606663VISUFIT 1000 Platform000000-2194-446000000-2194-4462021-01-01
04250668606694i.Terminal 2000000-1898-991000000-1898-9912021-01-01
04250668606755i.Profiler plus000000-2358-727000000-2358-7272021-01-01
04250668606670Avatar Generation000000-2351-295000000-2351-2952021-01-01
04250668606724VISUSCREEN 500000000-2087-230000000-2087-2302021-01-01
04250668606717i.Terminal 2000000-2408-310000000-2408-3102021-01-22
04250668606731VISUSCREEN 100000000-2069-910000000-2069-9102021-01-01
04250668606632ATLAS Review for i. Profiler plus000000-2360-422000000-2360-4222021-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250668606649i.Terminal mobileCarl Zeiss Vision GmbHHMM2021-01-01
04250668606687VISUFIT 1000Carl Zeiss Vision GmbHHMM2021-01-01
04250668606694i.Terminal 2Carl Zeiss Vision GmbHHMM2021-01-01