FDA.reportPublic FDA data

ATLAS Review for i. Profiler plus

Primary DI
04250668606632
Brand
ATLAS Review for i. Profiler plus
Company
Carl Zeiss Vision GmbH
Model
000000-2360-422
Catalog number
000000-2360-422
Device description
N/A
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
OUGMedical device data system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250668606632PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250668606632042506686066324250668606632

GMDN Terms#

Term, Definition table
TermDefinition
Corneal topography system application softwareAn individual software application program or group of programs, routines or algorithms intended to add specific computer assisted display, processing and/or analysis capabilities to a corneal topography system or system analyser. A basic set of applications programs and routines are included with such systems and can be upgraded to correct programming errors or to add new system capabilities. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

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
04250668607172i.Terminal go000000-2408-309000000-2408-3092022-12-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150006038N/AMEDTRONIC, INC.OUG2026-05-23
04931921049464NANIHON KOHDEN CORPORATIONOUG2026-05-20
04931921111697NANIHON KOHDEN CORPORATIONOUG2026-05-20
00199150021277NAMEDTRONIC, INC.OUG2026-05-02
00199150042784NAMEDTRONIC, INC.OUG2026-04-30
00199874112060CliniSphereMonitored Therapeutics, Inc.OUG2026-04-28
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESOUG2026-04-24
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00199150002191N/AMEDTRONIC, INC.OUG2026-04-02
05404028001158Mimics FlowMaterialise NVOUG2026-03-23
05404028001172SurgiCase OnlineMaterialise NVOUG2026-03-23
05404028001189ProPlan CMF Materialise NVOUG2026-03-23
00763000994914NAMEDTRONIC, INC.OUG2026-03-22
00382904450106BD Veritor™ InfoWiFi ModuleBECTON, DICKINSON AND COMPANYOUG2026-03-13
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
04035479189211PatientApp 2.9BIOTRONIK SE & Co. KGOUG2026-03-04
07350149360033PD Care SystemPainDrainer ABOUG2026-03-04
00860015454706RocotoRocoto Inc.OUG2026-02-26
00860015454713RocotoRocoto Inc.OUG2026-02-26
00860015454720RocotoRocoto Inc.OUG2026-02-26
00860015454737RocotoRocoto Inc.OUG2026-02-26
00860015454768RocotoRocoto Inc.OUG2026-02-26
00860015454775RocotoRocoto Inc.OUG2026-02-26
00840241600412Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-02-04
00199150002184NAMEDTRONIC, INC.OUG2026-02-01
03770034761006LIMSTARHOPI MEDICALOUG2026-01-28
03770034761013MINILIMHOPI MEDICALOUG2026-01-28
03770034761020FMCHOPI MEDICALOUG2026-01-28