FDA.reportPublic FDA data

SENSIMED Triggerfish® Software

Primary DI
07640153470157
Brand
SENSIMED Triggerfish® Software
Company
Sensimed SA
Model
V3
Catalog number
ST8000
Device description
Computer software for the configuration of SENSIMED Triggerfish® monitoring session and subsequent downloading, display and analysis of data from these sessions
Published
2017-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
PLZOcular Pattern Recorder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLZOcular Pattern RecorderOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN140017000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN140017000SENSIMED TRIGGERFISHSensimed AG2016-03-04PLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640153470157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640153470157076401534701577640153470157

GMDN Terms#

Term, Definition table
TermDefinition
Ocular volume ambulatory recording system softwareA software program intended to display and analyse recorded data produced by an ocular volume ambulatory recording system, to indicate patterns of intraocular pressure (IOP) fluctuation (e.g., to support patients at risk of glaucoma progression).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41216219191info@sensimed.ch

Regulatory Flags#

DUNS number
482491177
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640153470126SENSIMED Triggerfish® Recorder Sleeve004ST40012017-06-20
07640153470133SENSIMED Triggerfish® RecorderR.V.4.1ST50002017-06-20
07640153470010SENSIMED Triggerfish® Sensor STEEPS.V.4ST10012017-06-20
07640153470027SENSIMED Triggerfish® Sensor MEDIUMM.V.4ST10022017-06-20
07640153470034SENSIMED Triggerfish® Sensor FLATF.V.4ST10032017-06-20
07640153470041SENSIMED Triggerfish® Sensor STEEPS.V.4BO3S2017-06-20
07640153470058SENSIMED Triggerfish® Sensor MEDIUMM.V.4BO3M2017-06-20
07640153470065SENSIMED Triggerfish® Sensor FLATF.V.4BO3F2017-06-20
07640153470072SENSIMED Triggerfish® Sensor SMFSMF.V.4BO3SMF2017-06-20
07640153470089SENSIMED Triggerfish® Antenna LEFTAL.3ST20012017-06-20
07640153470096SENSIMED Triggerfish® Antenna RIGHTAR.3ST20022017-06-20
07640153470102SENSIMED Triggerfish® Antenna LEFTAL.3BO3AL2017-06-20
07640153470119SENSIMED Triggerfish® Antenna RIGHTAR.3BO3AR2017-06-20
07640153470140SENSIMED Triggerfish® Data CableDC.V.5.1ST50102017-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640153470010SENSIMED Triggerfish® Sensor STEEPSensimed SAPLZ2017-06-20
07640153470027SENSIMED Triggerfish® Sensor MEDIUMSensimed SAPLZ2017-06-20
07640153470034SENSIMED Triggerfish® Sensor FLATSensimed SAPLZ2017-06-20
07640153470041SENSIMED Triggerfish® Sensor STEEPSensimed SAPLZ2017-06-20
07640153470058SENSIMED Triggerfish® Sensor MEDIUMSensimed SAPLZ2017-06-20
07640153470065SENSIMED Triggerfish® Sensor FLATSensimed SAPLZ2017-06-20
07640153470072SENSIMED Triggerfish® Sensor SMFSensimed SAPLZ2017-06-20
07640153470089SENSIMED Triggerfish® Antenna LEFTSensimed SAPLZ2017-06-20
07640153470096SENSIMED Triggerfish® Antenna RIGHTSensimed SAPLZ2017-06-20
07640153470102SENSIMED Triggerfish® Antenna LEFTSensimed SAPLZ2017-06-20
07640153470119SENSIMED Triggerfish® Antenna RIGHTSensimed SAPLZ2017-06-20
07640153470126SENSIMED Triggerfish® Recorder SleeveSensimed SAPLZ2017-06-20
07640153470133SENSIMED Triggerfish® RecorderSensimed SAPLZ2017-06-20
07640153470140SENSIMED Triggerfish® Data CableSensimed SAPLZ2017-06-20