AccessGUDID - DEVICE: SENSIMED Triggerfish® Sensor STEEP (07640153470010)

GUDID

Device Identifier (DI) Information

Brand Name: SENSIMED Triggerfish® Sensor STEEP
Version or Model: S.V.4
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ST1001
Company Name: Sensimed SA

Primary DI Number: 07640153470010
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 482491177 *Terms of Use

Device Description: A single unit of STEEP SENSIMED Triggerfish® Sensor

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62111	Ocular volume ambulatory recording system sensor	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PLZ	Ocular Pattern Recorder

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN140017	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 55 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 20.671 and 31.302 Inches of Mercury
Handling Environment Temperature: between 10 and 35 Degrees Celsius
Handling Environment Humidity: between 30 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 23.624 and 31.302 Inches of Mercury

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 14.1 Millimeter

Device Record Status

Public Device Record Key: 505538f3-34c5-4aef-820f-f666cf6cf9ad
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: June 20, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +41216219191
Email: info@sensimed.ch

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