FDA.reportPublic FDA data

SENSIMED Triggerfish® Recorder Sleeve

Primary DI
07640153470126
Brand
SENSIMED Triggerfish® Recorder Sleeve
Company
Sensimed SA
Model
004
Catalog number
ST4001
Device description
A box of ten SENSIMED Triggerfish® Recorder Sleeve
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
07640153470126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640153470126076401534701267640153470126

GMDN Terms#

Term, Definition table
TermDefinition
Personal device holder, single-useA patient-worn, flexible device designed to hold a portable medical device (e.g., long-term recorder, portable oxygen equipment, urine collection bag) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a bag, pouch, strap, belt, or clothing. 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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
07640153470096SENSIMED Triggerfish® Antenna RIGHTSensimed SAPLZ2017-06-20
07640153470102SENSIMED Triggerfish® Antenna LEFTSensimed SAPLZ2017-06-20
07640153470119SENSIMED Triggerfish® Antenna RIGHTSensimed SAPLZ2017-06-20
07640153470133SENSIMED Triggerfish® RecorderSensimed SAPLZ2017-06-20
07640153470140SENSIMED Triggerfish® Data CableSensimed SAPLZ2017-06-20
07640153470157SENSIMED Triggerfish® SoftwareSensimed SAPLZ2017-06-20