FDA.reportPublic FDA data

SENSIMED Triggerfish® Antenna RIGHT

Primary DI
07640153470096
Brand
SENSIMED Triggerfish® Antenna RIGHT
Company
Sensimed SA
Model
AR.3
Catalog number
ST2002
Device description
A single unit of SENSIMED Triggerfish® eye patch antenna for use around the right eye
Published
2017-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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
07640153470096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640153470096076401534700967640153470096

GMDN Terms#

Term, Definition table
TermDefinition
Ocular monitoring/recording system ambulatory antenna, single-useAn external component of an ocular monitoring/recording system intended to enable continuous, wireless extraction of data from an implantable or nonimplantable ocular sensor (e.g., used to detect intraocular pressure (IOP) fluctuation in patients at risk of glaucoma progression); it may also be intended to allow wireless power transfer from the parent device to the sensor. It is intended to be connected to the system monitor or reader and worn at close proximity to the eye (e.g., attached to an included eye patch) to achieve a constant link with the sensor. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure23.62 Inches of Mercury31.3 Inches of Mercury
Handling Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure20.67 Inches of Mercury31.3 Inches of Mercury
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius55 Degrees Celsius

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
No natural rubber latex
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
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
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
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