AccessGUDID - DEVICE: Octax NaviLase (04260604170028)

GUDID

Device Identifier (DI) Information

Brand Name: Octax NaviLase
Version or Model: 19310/0146
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 19310/0146
Company Name: Octax Microscience GmbH

Primary DI Number: 04260604170028
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 314169074 *Terms of Use

Device Description: This submission includes two assisted reproduction laser systems, the LaserShot M and the NaviLase. The LaserShot M is a static laser system where the embryo is moved to the laser by moving the stage of the microscope. The LaserShot M components include a laser module (1.48 micrometer infrared diode laser, class 1M), laser adapter to connect to the microscope, mirror block, laser objective (25X), USB camera, EyeWare Software, and an optional target pointer and footswitch. The NaviLase includes the same components as the LaserShot M, but also includes a motion module and a motion controller. These additional components allow the NaviLase to work in two modes, fixed and dynamic. In fixed mode, the NaviLase operates similarly to the LaserShot M. In dynamic mode, the laser can be directed to any location within the field of view. In addition, dynamic mode allows automated laser firing along a user-defined path (straight line, arc, etc.). The EyeWare software controls the device components, operates the laser, and takes images and records videos of embryo undergoing laser procedures. The software determines how many holes are drilled along this line and controls/restricts laser firing parameters to minimize localized heating of the embryo during these procedures. These laser devices have been designed to be fitted to compatible inverted microscopes.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	No
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?
61181	Assisted reproduction laser system	A portable, mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a low-intensity laser beam to ablate the zona pellucida of an embryo during in vitro fertilization (IVF), typically as part of laser-assisted embryo hatching or embryo biopsy. It is intended to be used in conjunction with a compatible inverted-stage light microscope and typically includes a combined laser/microscope objective, a control unit, a camera, and additional supportive devices (e.g., software, foot-switch).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MRX	System, Assisted Reproduction Laser

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K192008	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
Storage Environment Atmospheric Pressure: between 735 and 1060 millibar
Handling Environment Atmospheric Pressure: between 735 and 1060 millibar
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between -20 and 70 Degrees Celsius
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9f7c6951-d158-4561-87a2-5dd318d2de0e
Public Version Date: May 19, 2020
Public Version Number: 1
DI Record Publish Date: May 11, 2020