AccessGUDID - DEVICE: SENSIMED Triggerfish® Antenna RIGHT (07640153470119)

GUDID

Device Identifier (DI) Information

Brand Name: SENSIMED Triggerfish® Antenna RIGHT
Version or Model: AR.3
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BO3AR
Company Name: Sensimed SA

Primary DI Number: 07640153470119
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 482491177 *Terms of Use

Device Description: A box of three SENSIMED Triggerfish® eye patch antennae for use around the right eye

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":	Yes
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?
62112	Ocular monitoring/recording system ambulatory antenna, single-use	An 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.	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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 20039e42-6a30-497d-9815-a67233c83ef0
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: June 20, 2017