FDA.reportPublic FDA data

SENSIMED Triggerfish® Sensor STEEP

Primary DI
07640153470041
Brand
SENSIMED Triggerfish® Sensor STEEP
Company
Sensimed SA
Model
S.V.4
Catalog number
BO3S
Device description
A box of three STEEP SENSIMED Triggerfish® Sensors
Published
2017-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

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
07640153470041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640153470041076401534700417640153470041

GMDN Terms#

Term, Definition table
TermDefinition
Ocular volume ambulatory recording system sensorA sterile, electronic component of an ambulatory ocular volume recording system which is in the form of a contact lens containing a sensor designed to measure and transmit variations in ocular volume (i.e., circumferential changes at the corneoscleral area), to indicate patterns of intraocular pressure (IOP) fluctuation. It is worn during daily activities and sleep (e.g., by patients at risk of glaucoma progression). It is powered by and wirelessly communicates with a patient-worn transceiver which is connected to a recorder. Recorded data is displayed and analysed by an off-the-shelf computing device (e.g., laptop) using dedicated software. This is a single-use device.

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
Expiration date on label
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
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
07640153470157SENSIMED Triggerfish® SoftwareV3ST80002017-06-20

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
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
07640153470157SENSIMED Triggerfish® SoftwareSensimed SAPLZ2017-06-20